Objectively Measured Sleep Duration and Health-Related Quality of Life in Older Adults with Metabolic Syndrome: A One-Year Longitudinal Analysis of the PREDIMED-Plus Cohort

Ci a ion: Ma cos-Delgado, A.; Ma ín-Sánchez, V.; Ma ínez- González, M.Á.; Co ella, D.; Salas-Sal adó, J.; Sch öde , H.; Ma ínez, A.; Alonso-Gómez, Á.M.; Wä nbe g, J.; Vioque, J.; e al. Objec i ely Measu ed Sleep Du a ion and Heal h-Rela ed Quali y o Li e in Olde Adul s wi h Me abolic Synd ome: A One-Yea Longi udinal Analysis o he PREDIMED-Plus Coho . Nu ien s 2024,16, 2631. h ps://doi.o g/10.3390/nu16162631 Academic Edi o : Sil ia Sa as ano Recei ed: 18 July 2024 Re ised: 30 July 2024 Accep ed: 31 July 2024 Published: 9 Augus 2024 Copy igh : © 2024 by he au ho s. Licensee MDPI, Basel, Swi ze land. This a icle is an open access a icle dis ibu ed unde he e ms and condi ions o he C ea i e Commons A ibu ion (CC BY) license (h ps:// c ea i ecommons.o g/licenses/by/ 4.0/). nu ien s A icle Objec i ely Measu ed Sleep Du a ion and Heal h-Rela ed Quali y o Li e in Olde Adul s wi h Me abolic Synd ome: A One-Yea Longi udinal Analysis o he PREDIMED-Plus Coho Alba Ma cos-Delgado 1,2,3,* , Vicen e Ma ín-Sánchez 1,2,3 , Miguel Ángel Ma ínez-González 4,5,6 , Dolo es Co ella 3,7 , Jo di Salas-Sal adó4,8,9 , Helmu Sch öde 4,10 , Al edo Ma ínez 4,11,12 , Ángel M. Alonso-Gómez 4,13 , Julia Wä nbe g 4,14 , Jesús Vioque 3,15 , Do a Romague a 4,16 , JoséLópez-Mi anda 4,17, Ramon Es uch 4,18 , F ancisco J. Tinahones 4,19, JoséM. San os-Lozano 4,20, Jacqueline Ál a ez-Pé ez 4,21 , Au o a Bueno-Ca anillas 3,22,23 , Naomi Cano-Ibáñez 3,22,23 , Ca men Amezcua-P ie o 3,22 , Na alia He nández-Segu a 1,2 , Josep A. Tu 3,24 , Xa ie Pin ó4,25 , Miguel Delgado-Rod íguez 12,26 , Pila Ma ía-Ma ín 27 , Josep Vidal 28,29 , Clo ilde Vázquez 4,30 , Lidia Daimiel 4,31,32 , Emili Ros 4,33 , Es e anía Toledo 4,5 , Tany E. Ga cidueñas-Fimb es 4,8,9 , Judi h Viaplana 28,29, E a M. Asensio 3,7 , Ma ía D. Zomeño 4,10, An onio Ga cia-Rios 4,17, Alejand o Oncina-Cáno as 14,15 , F ancisco Ja ie Ba ón-López 14 , Napoleón Pé ez-Fa inos 14 , Ca men Sayon-O ea 4,5 , Aina M. Galmés-Panadés4,16,34 , Rosa Casas 4,18 , Lucas Tojal-Sie a 4,13 , Ana M. Gómez-Pé ez 4,19 , Pila Buil-Co siales 5, Jesús F. Ga cía-Ga ilán4,8,9 , Ca olina O ega-Azo ín3,7 , Olga Cas añe 10 , Pa icia J. Peña-O ihuela 4,17, Sand a González-Palacios 14,15 , Nancy Babio 4,8,9 , Mon se Fi ó10 and Ja ie Nie o 35 1Facul y o Heal h Sciences, Depa men o Biomedical Sciences, A ea o P e en i e Medicine and Public Heal h, Uni e sidad de León, 24007 León, Spain; [email p o ec ed] (V.M.-S.); [email p o ec ed] (N.H.-S.) 2The Resea ch G oup in Gene-En i onmen and Heal h In e ac ions, Ins i u e o Biomedicine (IBIOMED), Uni e sidad de León, 24007 León, Spain 3CIBER de Epidemiología y Salud Pública (CIBERESP), Ins i u o de Salud Ca los III, 28222 Mad id, Spain; dolo es.co ella@u .es (D.C.); [email p o ec ed] (J.V.); abueno@ug .es (A.B.-C.); ncaiba@ug .es (N.C.-I.); ca mezcua@ug .es (C.A.-P.); [email p o ec ed] (J.A.T.); e a.m.asensio@u .es (E.M.A.); ca olina.o ega@u .es (C.O.-A.) 4Cen o de In es igación Biomédica en Red Fisiopa ología de la Obesidad y la Nu ición (CIBEROBN), Ins i u e o Heal h Ca los III, 28222 Mad id, Spain; mama inez@una .es (M.Á.M.-G.); jo di.salas@u .ca (J.S.-S.); [email p o ec ed] (H.S.); jal m z@una .es (A.M.); [email p o ec ed] (Á.M.A.-G.); [email p o ec ed] (J.W.); [email p o ec ed] (D.R.); [email p o ec ed] (J.L.-M.); es [email p o ec ed] (R.E.); [email p o ec ed] (F.J.T.); [email p o ec ed] (J.M.S.-L.); jal a ez@p oyin es.ulpgc.es (J.Á.-P.); [email p o ec ed] (X.P.); [email p o ec ed] (C.V.); [email p o ec ed] (L.D.); e [email p o ec ed] (E.R.); e oledo@una .es (E.T.); [email p o ec ed].ca (T.E.G.-F.); [email p o ec ed] (M.D.Z.); [email p o ec ed] (A.G.-R.); [email p o ec ed].es (C.S.-O.); [email p o ec ed] (A.M.G.-P.); [email p o ec ed] (R.C.); [email p o ec ed] (L.T.-S.); [email p o ec ed] (A.M.G.-P.); jesus ancisco.ga cia@iisp .ca (J.F.G.-G.); [email p o ec ed] (P.J.P.-O.); nancy.babio@u .ca (N.B.) 5Depa men o P e en i e Medicine and Public Heal h, Na a a Ins i u e o Heal h Resea ch (IdiSNA), Uni e si y o Na a a, 31009 Pamplona, Spain; [email p o ec ed] 6Depa men o Nu i ion, Ha a d T.H. Chan School o Public Heal h, Bos on, MA 02124, USA 7Depa men o P e en i e Medicine, Uni e si y o Valencia, 46008 Valencia, Spain 8 Uni a de Nu ició, Depa amen de Bioquímica i Bio ecnologia, Uni e si a Ro i a i Vi gili, 43206 Reus, Spain 9Ins i u d’In es igacióSani à ia Pe e Vi gili (IISPV), 43204 Reus, Spain 10 Uni o Ca dio ascula Risk and Nu i ion, Ins i u Hospi al del Ma de In es igaciones Médicas Municipal d’In es igacióMédica (IMIM), 08003 Ba celona, Spain; [email p o ec ed] (O.C.); [email p o ec ed] (M.F.) 11 Depa men o Nu i ion, Food Sciences, and Physiology, Cen e o Nu i ion Resea ch, Uni e si y o Na a a, 31009 Pamplona, Spain 12 P ecision Nu i ion and Ca diome abolic Heal h P og am, IMDEA Food, CEI UAM + CSIC, 28222 Mad id, Spain; [email p o ec ed] Nu ien s 2024,16, 2631. h ps://doi.o g/10.3390/nu16162631 h ps://www.mdpi.com/jou nal/nu ien s Nu ien s 2024,16, 2631 2 o 18 13 Bioa aba Heal h Resea ch Ins i u e, Ca dio ascula , Respi a o y and Me abolic A ea, Osakide za Basque Heal h Se ice, A aba Uni e si y Hospi al, Uni e si y o he Basque Coun y UPV/EHU, 01004 Vi o ia-Gas eiz, Spain 14 EpiPHAAN Resea ch G oup, School o Heal h Sciences, Ins i u o de In es igación Biomédica de Málaga (IBIMA), Uni e si y o Málaga, 29010 Málaga, Spain; [email p o ec ed] (A.O.-C.); [email p o ec ed] (F.J.B.-L.); [email p o ec ed] (N.P.-F.); [email p o ec ed] (S.G.-P.) 15 Ins i u o de In es igación Sani a ia y Biomédica de Alican e, Uni e sidad Miguel He nández (ISABIAL-UMH), 03202 Alican e, Spain 16 Heal h Resea ch Ins i u e o he Balea ic Islands (IdISBa), 07012 Palma de Mallo ca, Spain 17 Depa men o In e nal Medicine, Maimonides Biomedical Resea ch Ins i u e o Co doba (IMIBIC), Reina So ia Uni e si y Hospi al, Uni e si y o Co doba, 30110 Co doba, Spain 18 Depa men o In e nal Medicine, Ins i u d’In es igacions Biomèdiques Augus Pi Sunye (IDIBAPS), Hospi al Clinic, Ins i u de Rece ca en Nu icióy Segu e a Alimen a ia (INSA-UB), Uni e si y o Ba celona, 08001 Ba celona, Spain 19 Vi gen de la Vic o ia Hospi al, Depa men o Endoc inology, Ins i u o de In es igación Biomédica de Málaga (IBIMA), Uni e si y o Málaga, 29010 Málaga, Spain 20 Resea ch Uni , Depa men o Family Medicine, Dis i o Sani a io A ención P ima ia Se illa, 41006 Se illa, Spain 21 Resea ch Ins i u e o Biomedical and Heal h Sciences (IUIBS), Uni e si y o Las Palmas de G an Cana ia, 35010 Las Palmas de G an Cana ia, Spain 22 Depa men o P e en i e Medicine and Public Heal h, Uni e si y o G anada, 18071 G anada, Spain 23 Ins i u o de In es igación Biosani a ia de G anada (ibs.GRANADA), 18071 G anada, Spain 24 Resea ch G oup on Communi y Nu i ion & Oxida i e S ess, Uni e si y o Balea ic Islands, 07012 Palma de Mallo ca, Spain 25 Lipids and Vascula Risk Uni , In e nal Medicine, Hospi al Uni e si a io de Bell i ge-IDIBELL, Hospi ale de Llob ega , 08901 Ba celona, Spain 26 Di ision o P e en i e Medicine, Facul y o Medicine, Uni e si y o Jaén, 23003 Jaén, Spain 27 Depa men o Endoc inology and Nu i ion, Ins i u o de In es igación Sani a ia Hospi al Clínico San Ca los (IdISSC), 28040 Mad id, Spain; [email p o ec ed] 28 CIBER Diabe es y En e medades Me abólicas (CIBERDEM), Ins i u o de Salud Ca los III (ISCIII), 28222 Mad id, Spain; [email p o ec ed] (J.V.); [email p o ec ed] (J.V.) 29 Depa men o Endoc inology, Ins i u d’In es igacions Biomédiques Augus Pi Sunye (IDIBAPS), Hospi al Clinic, Uni e si y o Ba celona, 08001 Ba celona, Spain 30 Depa men o Endoc inology and Nu i ion, Hospi al Fundación Jimenez Díaz, Ins i u o de In es igaciones Biomédicas IISFJD, Uni e si y Au onoma, 28049 Mad id, Spain 31 Nu i ional Con ol o he Epigenome G oup, P ecision Nu i ion and Obesi y P og am, IMDEA Food, CEI UAM + CSIC, 28222 Mad id, Spain 32 Depa amen o de Ciencias Fa macéu icas y de la Salud, Facul ad de Fa macia, Uni e sidad San Pablo-CEU, CEU Uni e si ies, U banización Mon ep íncipe, 28660 Boadilla del Mon e, Spain 33 Lipid Clinic, Depa men o Endoc inology and Nu i ion, Ins i u d’In es igacions Biomèdiques Augus Pi Sunye (IDIBAPS), Hospi al Clínic, 08001 Ba celona, Spain 34 Physical Ac i i y and Spo Sciences Resea ch G oup (GICAFE), Ins i u e o Educa ional Resea ch and Inno a ion (IRIE), Uni e si y o he Balea ic Island, 07122 Palma, Spain 35 College o Public Heal h and Human Sciences, O egon S a e Uni e si y, Co allis, OR 97330, USA; ja ie [email p o ec ed] *Co espondence: ama [email p o ec ed]; Tel.: +34-606784373 Abs ac : The aim o ou c oss-sec ional and longi udinal s udy is o assess he ela ionship be ween day ime and nigh - ime sleep du a ion and heal h- ela ed quali y o li e (HRQoL) in adul s wi h me abolic synd ome a e a 1-yea heal hy li es yle in e en ion. Analysis o he da a om 2119 Span- ish adul s aged 55–75 yea s om he PREDIMED-Plus s udy was pe o med. Sleep du a ion was assessed using a w is -wo n accele ome e . HRQoL was measu ed using he SF-36 ques ionnai e. Linea eg ession models adjus ed o socioeconomic and li es yle ac o s and mo bidi y we e de- eloped. In c oss-sec ional analyses, pa icipan s wi h ex eme nigh - ime sleep du a ion ca ego ies showed lowe physical componen summa y sco es in Models 1 and 2 [ β -coe icien (95% con i- dence in e al) <6 h s. 7–9 h: − 2, 3 ( − 3.8 o − 0.8); p= 0.002. >9 h s. 7–9 h: − 1.1 ( − 2.0 o − 0.3); p= 0.01 ]. Pa icipan s who sleep less han 7 h a nigh and ake a nap a e associa ed wi h highe men al componen summa y sco es [ β -coe icien (95% con idence in e al) 6.3 (1.3 o 11.3); p= 0.01]. No di e ences be ween nigh - ime sleep ca ego ies and 12-mon h changes in HRQoL we e obse ed. In conclusion, in c oss-sec ional analyses, ex emes in noc u nal sleep du a ion a e ela ed o lowe Nu ien s 2024,16, 2631 3 o 18 physical componen summa y sco es and napping is associa ed wi h highe men al componen summa y sco es in olde adul s who sleep less han 7 h a nigh . Keywo ds: sleep du a ion; day ime sleep du a ion; me abolic synd ome; heal h- ela ed quali y o li e; quali y o li e; nap 1. In oduc ion Sleep habi s in oday’s socie y ha e changed compa ed wi h hose o ou ances o s. In gene al, we sleep less, ha e less quali y sleep and a e mo e unlikely o nap [ 1 ]. The main causes o his a e sugges ed o be a i icial ligh , using new echnologies, wo king hou s and he pace o li e [1–4]. Fo decades, sleep- ela ed p oblems ha e been inc easing exponen ially [ 5 , 6 ]; be ween 10 and 30% o he popula ion epo s sleeping less han 6 h a day (depending on coun y) [ 7 ], app oxima ely 40% ela es o ha ing had a es ul nigh ’s sleep [ 8 , 9 ] and he consump ion o sleep medica ions has sky ocke ed [10], u ning in o a public heal h challenge. Acco ding o he Su ey o Heal h Ageing and Re i emen in Eu ope, 24.3% o olde adul s in Spain ha e sleep p oblems [ 11 ], 54.3% epo ed sleeping less han se en hou s (male 56.2% and emale 52.8%) [ 9 ] and 16% ake a daily nap, a pe cen age ha inc eases wi h lexible wo king hou s o e i emen [11]. E idence shows ha a sleep de ici is a isk ac o o inc eased mo ali y and ma- jo ch onic diseases like ca dio ascula diseases [ 12 ], hype ension, obesi y, ype 2 dia- be es [13,14] o me abolic synd ome (Me S) [ 15 ]. Fu he mo e, a s ong associa ion has been shown be ween sleep du a ion and men al illnesses such as anxie y o dep ession [16,17]. In ecen yea s, he pa adigm in sleep esea ch has shi ed. Fo mos o he las ew decades, esea ch ocused mos ly on sleep pa hologies such as sleep apnea, insomnia and na colepsy. In ecen yea s, howe e , he e has been inc easing a en ion on a b oade and mo e holis ic app oach, namely on he ole o sleep heal h in all aspec s o li e and heal h in gene al [ 1 , 18 ]. Heal h- ela ed quali y o li e (HRQoL), a measu e o indi idual well-being, has been shown o be nega i ely impac ed by sleep de iciency, ei he in e ms o quali y o quan i y. Howe e , i is no en i ely clea which HRQoL componen s a e mos a ec ed. Fu he mo e, mos published s udies a e c oss-sec ional, use sel - epo ed measu es o sleep du a ion and/o do no ake in o accoun he e ec ha day ime sleep (naps) may ha e on HRQoL [19–22]. The e is no consensus in he scien i ic li e a u e ega ding he e ec s o naps on heal h ou comes. I seems ha long naps, las ing mo e han 1 h, may be a symp om o consequence o a noc u nal sleep diso de and ha e been ound o be associa ed wi h an inc eased isk o obesi y, ype 2 diabe es o Me S [ 23 , 24 ]. Howe e , sho naps be ween 15 and 30 min/d ha e been associa ed wi h an inc ease in cogni i e unc ion, g ea e memo y e en ion, eco e y om a igue and inc eased ale ness [25–27]. Consequen ly, hey could be a key elemen in imp o ing he popula ion’s HRQoL. The e o e, he aim o ou c oss-sec ional and longi udinal s udy is o assess he e ec s o day ime and nigh - ime sleep on HRQoL in olde adul s wi h Me S a e a 1-yea heal hy li es yle in e en ion. 2. Ma e ials and Me hods 2.1. S udy Design and Pa icipan s The PREDIMED-Plus s udy is a 6-yea ongoing, mul icen e , con olled, andomized in e en ion s udy wi h wo pa allel g oups o he p ima y p e en ion o ca dio ascula disease, in ol ing 6874 people ec ui ed in 23 Spanish cen e s. The s udy me hods ha e been epo ed elsewhe e [ 28 ] and a e a ailable on he PREDIMED-Plus websi e (h p:// www.p edimedplus.com, accessed on 1 May 2024). Eligible pa icipan s we e communi y- dwelling men (55–75 yea s old) and women (60–75 yea s old), wi h a body mass index Nu ien s 2024,16, 2631 4 o 18 (BMI) be ween ≥ 27 and <40 kg/m 2 and who me a leas 3 componen s o he Me S de ini ion [ 29 ]. The in e en ion g oup ecei ed an in ense in e en ion wi h an ene gy- es ic ed adi ional Medi e anean die (e MedDie ), physical ac i i y (PA) p omo ion and mo i a ional suppo o lose weigh . The con ol g oup ecei ed gene al ecommenda ions abou he Medi e anean die and heal hy guidelines. Ou o 6874 pa icipan s, da a de i ed om accele ome y we e a ailable in a subsample o 2223 pa icipan s. Acco ding o p o ocol, accele ome e s we e p o ided o a subse o pa icipan s (50% o pa icipan s in he in ensi e in e en ion g oup and 20% o hose in he con ol g oup) in o de o quan i y PA and sleep. One hund ed and ou pa icipan s we e excluded owing o incomple e sleep o co a ia e da a. The inal sample size was 2119 pa icipan s a baseline and 1-yea ollow-up (Supplemen al Figu e S1). The ial was app o ed by he Ins i u ional Re iew Boa d o all ec ui men cen e s whe e he s udy was conduc ed, acco ding o he e hical s anda ds o he Decla a ion o Helsinki. The ial was e ospec i ely egis e ed in he In e na ional S anda d Randomized Con olled T ial egis y (ISRCTN: h p://www.is c n.com/ISRCTN89898870, accessed on 1 May 2024). All pa icipan s p o ided w i en in o med consen . 2.2. P incipal P edic o Va iable: Objec i ely Assessed Sleep by Accele ome y The pa icipan s wo e a w is -wo n accele ome e on hei nondominan w is o 8 consecu i e 24 h days (GENEAc i , Ac i Insigh s L d., Kimbol on, UK). The GENEAc i con ains a iaxial accele ome e cap u ing accele a ions in a ange o ± 8 G’s and i was se a a sampling a e o 40 Hz. The moni o is o ally wa e p oo , and hey we e asked o no emo e i du ing wa e -based ac i i ies (i.e., showe ing, ba hing o swimming). Raw da a we e downloaded a each s udy cen e using he GENEAc i PC so wa e 1.2 (Ac i Insigh s L d., Camb idgeshi e, UK) as bina y iles (bin) and we e uploaded o a common se e a he s udy coo dina ing cen e a he Uni e si y o Malaga. All aw da a iles we e p ocessed on an ongoing basis wi h he open-sou ce R package GGIR . 2.4–3 (h ps://c an. -p ojec .o g, accessed on 1 May 2024) [30]. The sleep de ec ion algo i hm HDCZA ( he Heu is ic Algo i hm looking a Dis ibu- ion o Change in Z-Angle), a ailable as pa o he GGIR package [ 31 ], was used o iden i y he sleep pe iod ime window (SPT window, which e e s o he ime window s a ing a sleep onse and ending when he pe son wakes up a e he las sleep episode o he nigh ). Open-sou ce so wa e such as GGIR allows aw da a o be p ocessed in an iden ical manne ega dless o moni o s, and equi alen alues o sleep es ima es ha e been shown be ween he mos common moni o s used in epidemiologic s udies [ 32 ]. Day ime napping was es ima ed as a pe iod o sus ained inac i i y du ing he day, de ec ed as he absence o change in a m angle g ea e han 5 deg ees o a leas 5 min [31]. Days when he accele ome e egis e ed a alid nigh eco d we e conside ed as alid, and only esul s om pa icipan s wi h a leas wo alid eco d days (and nigh s) we e included in he analyses. 2.3. Ou come Va iable: Heal h-Rela ed Quali y o Li e (HRQoL) The dependen a iable was HRQoL a baseline and 1-yea ollow-up, measu ed using he Spanish e sion o he SF-36 ques ionnai e [ 33 , 34 ]. This ques ionnai e consis ed o 36 i ems ha assessed eigh dimensions o scales: physical unc ion (PF), physical ole (RP), bodily pain (BP), gene al heal h (GH), i ali y (VT), social unc ion (SF), emo ional ole (RE) and men al heal h (MH). These dimensions we e used o de ine wo heal h componen summa ies: he physical componen summa y (PCS) and he men al componen summa y (MCS). Each i em ecei ed a nume ical sco e ha was encoded, summed up and pu on a scale om 0 o 100. The highe he sco e, he be e quali y o li e in he analyzed ield [ 35 ]. The eliabili y o he scale used o de e mine he alues o he Spanish popula ion o ≥ 60 yea s was highe han he p oposed s anda d o C onbach’s α , 0.7 [ 36 ], and has been p e iously used o measu e HRQoL in olde adul s [37,38]. Nu ien s 2024,16, 2631 5 o 18 2.4. Co a ia es A baseline, sel - epo ed in o ma ion was ob ained by in e iew o sociodemo- g aphic a iables: sex (men/women), age (yea s), ma i al s a us (ma ied o li ing wi h a pa ne , di o ced o widowed o single), labo s a us (ac i e, e i ed, unemployed o household wo k) and educa ional le el ( ≤ p ima y, seconda y o uni e si y). The li es yle co a ia es o smoking s a us (cu en , o me o ne e smoke ), ca eine d inks/day (mg/d), alcohol d inks/day (g/d) and leisu e ime spen wa ching TV (h/wk) we e also collec ed h ough he baseline ques ionnai e. The Medi e anean die adhe ence was measu ed h ough a 17-i em ques ionnai e by a ained in e iewe [39]. Body mass index (kg/m 2 ) was calcula ed om weigh and heigh , measu ed unde s anda dized condi ions wi h ligh clo hing and no shoes, using elec onic scales and po able ex endable s adiome e s. Mean alues o he wo measu emen s we e used o he analyses acco ding o he PREDIMED-Plus p o ocol. Physical ac i i y in ensi ies we e objec i ely es ima ed by accele ome y and calcula ed and classi ied using a p e iously p oposed h eshold o ENMO (Euclidean No m Minus One) in he nondominan w is : inac i i y (<45 mg), ligh ac i i y (45–99.9 mg) and mode a e- o- igo ous ac i i y (MVPA, >100 mg) [40]. PA was ca ego ized, acco ding o WHO ecommenda ions, as ≥ 150 min/week (ac- i e/non ac i e) [41]. Finally, he ollowing physician-diagnosed diseases we e sel - epo ed: hype en- sion (yes/no), ype 2 diabe es melli us (yes/no), seda i e ea men (yes/no), dep ession (yes/no), sleep apnea (yes/no) and ch onic obs uc i e pulmona y disease (yes/no). 2.5. S a is ical Analysis 2.5.1. C oss-Sec ional Analysis Fi s , he analysis o baseline cha ac e is ics was ca ied ou in he en i e sample acco ding o ou ca ego ies o nigh - ime sleep du a ion, as de ined in p e ious s udies (<6, ≥ 6–<7, ≥ 7–<9 and ≥ 9 h/day (h/d)) [ 19 , 21 ]. Means (s anda d de ia ion, SD) o medians (in e qua ile ange, IQ) we e used o quan i a i e a iables wi h no mal o non- no mal dis ibu ion, espec i ely, and absolu e and ela i e equencies (n, %) we e used o quali a i e a iables. p-Values o di e ences be ween ca ego ies o nigh - ime sleep du a ion we e calcula ed using a chi-squa ed es o ANOVA o ca ego ical and con inuous a iables, espec i ely. In cases o non-no mally dis ibu ed con inuous a iables, we pe o med a K uskal–Wallis es . Second, linea eg ession models we e de eloped wi h HRQoL a e 1-yea ollow-up as he dependen a iable and sleep du a ion as he main independen a iable (using ≥ 7–<9 h o sleep as e e ence ca ego y). Model 1 was a linea model adjus ed o age and sex; Model 2 was Model 1 plus ma i al s a us, labo s a us and educa ional le el; Model 3 was Model 2 plus li es yle ac o s (smoking s a us, ca eine d inks/day, alcohol d inks/day, leisu e ime spen wa ching TV, adhe ence o a Medi e anean die , BMI, PA and day ime sleep du a ion); and Model 4 was Model 3 plus mo bidi y (hype ension, ype 2 diabe es, seda i e ea men , dep ession, sleep apnea and ch onic obs uc i e pulmona y disease) and ea men assignmen . The Benjamini–Hochbe g p ocedu e (BH) was used as a co ec ion es . Because, in mos cases, he esul s om Models 1 and 2 we e i ually iden ical, only he la e a e shown in some ables. S a i ied analyses by sex we e also pe o med (Supplemen a y Ma e ial). Thi d, linea eg ession models we e used o s udy he associa ions be ween day ime sleep du a ion and HRQoL, s a i ied by nigh - ime sleep du a ion. The ca ego ies o day ime sleep du a ion we e <15, ≥ 15–<60 and ≥ 60 min/day (min/d). Analyses using 4 ca ego ies—spli ing he middle ca ego y in wo using 30 min/d as he cu -o —yield simila esul s. The ca ego y <15 min/d o day ime sleep was used as he e e ence. The ca ego ies o nigh - ime sleep du a ion we e <7, ≥ 7–<9 and ≥ 9 h/d. We could no main ain ou sleep ca ego ies due o he small numbe o pa icipan s who slep <6 h/d a nigh Nu ien s 2024,16, 2631 6 o 18 and had <15 min/d o day ime sleep. Linea eg ession models we e as desc ibed abo e, emo ing day ime sleep du a ion in Model 3. I was no possible o pe o m s a i ied analyses by sex due o insu icien samples in he ca ego ies o in e es . 2.5.2. Longi udinal Analysis To examine whe he nigh - and day ime sleep du a ion p edic ed changes in HRQoL, linea eg ession was ca ied ou , whe e he dependen a iable was di e ences in HRQoL be ween baseline and one yea a e he in e en ion and nigh /day sleep du a ion was he main independen a iable. Twel e-mon h changes in HRQoL we e exp essed as means (SD) and β - eg ession coe icien s and used o assess he 1-yea a e age changes in HRQoL associa ed wi h nigh - and day ime sleep du a ion a baseline. A posi i e β -coe icien means an imp o emen in HRQoL, while a nega i e coe icien means a wo sening. We de ined “clinically signi ican ” changes in HRQoL when he e was a leas a 5% change in he magni ude o he SF-36 sco e. Logis ic eg ession models we e ca ied ou wi h his cu -o poin o de ine he dependen a iable. In hese models, odds a ios (ORs) we e calcula ed: an OR abo e 1 quan i ies he likelihood o a clinically signi ican imp o emen in pa icipan s’ HRQoL, while an OR less han 1 indica es he isk o ha change being o he wo se. The ca ego ies o nigh - and day ime sleep we e as desc ibed abo e, as we e he models and po en ial con ounde s o which he analyses we e adjus ed. S a i ied analyses by sex, age, BMI and PA we e also pe o med excep o analyses acco ding o day ime sleep ca ego ies due o insu icien sample size. The analysis was pe o med wi h S a aCo p (College S a ion, TX, USA) 2019, S a a S a is ical So wa e: Release 16. 3. Resul s 3.1. Baseline Desc ip i e Cha ac e is ics Baseline cha ac e is ics in he o al sample and acco ding o ou ca ego ies o nigh - ime sleep du a ion a e shown in Table 1. The nigh - ime sleep du a ion mean (SD) in he o al sample (n= 2119) was 8.0 (1.3) h/d, he mean age (SD) was 65.0 (4.9) yea s and 47.4% o pa icipan s we e emale. Those pa icipan s sleeping ≥ 9 h we e olde and mo e likely o be women, e i ed, ha e a uni e si y deg ee and ne e ha e smoked. They we e also mo e likely o ha e lowe ligh and mode a e– igo ous PA le els, highe p e alence o dep ession and highe seda i e ea men use. The indi iduals sleeping <6 h showed highe ca eine and alcohol consump ion, spen mo e ime wa ching TV on he weekends and had highe day ime sleep du a ion. No signi ican di e ences in ma i al s a us, adhe ence o ene gy- es ic ed MedDie , hype ension, ype 2 diabe es, sleep apnea and ch onic lung disease we e ound. Rega ding he SF-36 sco e, lowe sco es a e obse ed o ex eme sleep du a ions, ob aining s a is ically signi ican di e ences in all scales excep o RE. Table 1. Baseline cha ac e is ics o he PREDIMED-Plus s udy pa icipan s ac oss ca ego ies o nigh - ime sleep du a ion. Ca ego ies o Nigh -Time Sleep Du a ion (h/d) p-Value To al <6 ≥6–<7 ≥7–<9 ≥9 n= 2119 n= 129 n= 316 n= 1247 n= 427 Sleep pa ame e s Nigh - ime sleep du a ion, Min–max, h/d 3.1–14.2 3.1–5.9 6.0–6.9 7.0–8.0 9.0–14.2 <0.001 Nigh - ime sleep du a ion, mean (SD), h/d 8.0 (1.3) 5.2 (0.7) 6.6 (0.3) 8.0 (0.5) 9.8 (0.7) <0.001 Napping du a ion, median (IQ), min/d 61.2 (37.8–91.2) 90 (69.0–139.8) 68.7 (42.0–103.2) 55.8 (33.0–81.6) 64.8 (40.8–97.2) <0.001 Age, mean (SD), yea s 65.0 (4.9) 64.7 (5.3) 64.0 (5.1) 64.9 (4.9) 66.3 (4.4) <0.001 Nu ien s 2024,16, 2631 7 o 18 Table 1. Con . Ca ego ies o Nigh -Time Sleep Du a ion (h/d) p-Value To al <6 ≥6–<7 ≥7–<9 ≥9 n= 2119 n= 129 n= 316 n= 1247 n= 427 Female, n(%) 1005 (47.4) 25 (19.4) 106 (33.5) 616 (33.5) 258 (60.4) <0.001 Labo s a us, n(%) Re i ed 1219 (57.5) 77 (59.7) 162 (51.3) 698 (56.0) 282 (66.0) <0.001 Educa ional le el, n(%) ≤P ima y educa ion 1062 (50.1) 56 (43.4) 129 (40.8) 611 (49.0) 66 (15.5) <0.001 Uni e si y educa ion 463 (21.9) 40 (31.0) 95 (30.1) 262 (21.0) 266 (62.3) Smoking, n(%) Ne e 919 (43.4) 36 (27.9) 112 (35.4) 555 (44.5) 216 (50.6) <0.001 Ca eine d inks/day, median (IQ), mg/day 21.4 (0–50) 21.4 (0–125) 7.1 (0–50) 21.4 (0–50) 3.3 (0–50) <0.001 Alcohol d inks/day, median (IQ), g/day 5.1 (0.7–14.8) 7.4 (1.5–28.4) 7.3 (1.5–18.6) 5.1 (0.7–14.7) 2.9 (0.0–11.8) <0.001 Leisu e ime spen wa ching TV, mean (SD), h/day Non-labo days 3.9 (3.3) 4.6 (7.7) 4.2 (5.2) 3.7 (2.0) 3.8 (1.9) 0.01 Seda i e ea men , n(%) 514 (24.3) 29 (22.5) 52 (16.5) 295 (23.7) 138 (32.3) <0.001 Dep ession, n(%) 472 (22.3) 23 (17.8) 51 (16.1) 274 (22.0) 124 (29.0) <0.001 BMI, mean (SD), kg/m232.6 (3.5) 33.4 (3.5) 32.9 (3.4) 32.4 (3.4) 32.8 (3.6) 0.004 PA, mean (SD) IPA 7.2 (1.7) 8.9 (2.6) 7.6 (1.7) 7.1 (1.6) 6.6 (1.4) <0.001 LPA 2.6 (1.1) 2.6 (1.3) 2.8 (1.1) 2.6 (1.1) 2.2 (0.9) <0.001 MVPA 40.2 (32.2) 40.1 (34.6) 42.1 (33.4) 41.8 (32.5) 34.0 (28.9) <0.001 HRQoL, SF-36 sco e, mean (SD), poin s (1-yea ollow-up) PF 79.3 (18.6) 78.3 (19.2) 80.9 (17.5) 80.2 (17.9) 75.7 (20.9) <0.001 RF 81.3 (33.3) 82.2 (32.4) 84.2 (30.6) 82.1 (32.6) 76.6 (36.9) 0.01 BP 65.9 (25.1) 66.3 (24.6) 67.7 (23.6) 66.9 (24.9) 61.6 (26.5) 0.001 GH 64.3 (17.0) 63.8 (16.7) 64.9 (16.4) 64.9 (17.0) 62.0 (17.2) 0.02 VT 65.1 (19.3) 65.2 (17.6) 67.1 (17.7) 65.7 (19.1) 61.6 (20.9) <0.001 SF 85.6 (19.3) 85.9 (20.4) 88.1 (17.5) 86.0 (19.2) 82.7 (20.0) 0.001 RE 90.3 (26.0) 92.2 (22.6) 91.1 (24.0) 90.6 (25.8) 88.2 (28.9) 0.27 MH 75.4 (17.8) 77.1 (16.0) 78.0 (15.5) 75.4 (17.7) 73.2 (19.6) 0.002 PCS 46.3 (8.4) 45.9 (8.5) 46.9 (8.0) 46.7 (8.3) 44.8 (9.1) <0.001 MCS 51.5 (9.3) 52.3 (8.7) 52.4 (8.2) 51.4 (9.3) 50.6 (10.2) 0.05 BMI: body mass index; BP: bodily pain; GH: gene al heal h; h/d: hou s/day; HRQoL: heal h- ela ed quali y o li e; IPA: inac i e physical ac i i y (h/a e age day)—cu -o in ensi y le el used o inac i i y (excluding SIBs) < 40 mg (<1.5 Me s); LPA: ligh physical ac i i y in bou s o a leas 1 min (accumula ed min/a e age day)—cu -o in ensi y le el o LPA is >40 mg (1.5 Me s) and <100 mg (3 Me s); MVPA: mode a e– igo ous physical ac i i y in bou s o a leas 1 min (accumula ed min/day)—cu -o in ensi y le el o MVPA is >100 mg (3 Me s); MH: men al heal h; MCS: agg ega ed men al dimensions; PA: physical ac i i y; PCS: agg ega ed physical dimensions; RE: emo ional ole; RF: ole unc ion; SF: social unc ion; VT: i ali y. p-Value o di e ences be ween ca ego ies o nigh - ime sleep du a ion was calcula ed by chi-squa ed es o ANOVA o ca ego ical and con inuous a iables, espec i ely. In cases o non-no mally dis ibu ed a iables, we pe o med K uskal–Wallis es . 3.2. C oss-Sec ional Analysis 3.2.1. Nigh -Time Sleep Du a ion Compa ed wi h hose in he ≥ 7–<9 h ca ego y, pa icipan s in ca ego ies ou side he ecommended ange o sleep du a ion (<6 h and ≥ 9 h) showed lowe PF, BP, VT, SF, GH and PCS sco es in he mul i a iable-adjus ed Models 1 and 2 (Table 2and Figu e 1). When con ounding li es yle a iables we e included in he model (Model 3), s a is ically signi ican associa ion was los in all dimensions excep o BP and PCS, al hough he e was s ill a dec ease in sco es in hose indi iduals who sleep mo e han 9 h. In he ully adjus ed model (Model 4), he associa ion be ween sleep du a ion and HRQoL dimensions was los . Nu ien s 2024,16, 2631 8 o 18 Nu ien s 2024, 16, x FOR PEER REVIEW 8 o 18 Figu e 1. Mul i a iable-adjus ed Model 3 and 4 β -coe icien s (95% con idence in e al) o dimensions o heal h- ela ed quali y o li e acco ding o nigh - ime sleep du a ion ca ego ies. Nu ien s 2024,16, 2631 9 o 18 Table 2. Mul i a iable-adjus ed β -coe icien s (95% con idence in e al) o heal h- ela ed quali y o li e acco ding o nigh - ime sleep du a ion ca ego ies. Ca ego ies o Nigh -Time Sleep Du a ion (h/d) <6 ≥6–<7 ≥7–<9 ≥9 n= 129 n= 316 n= 1247 n= 427 HRQoL β-Coe icien s (95% CI) p-Value β-Coe icien s (95% CI) p-Value β-Coe icien s (95% CI) p-Value β-Coe icien s (95% CI) p-Value PF −5.4 (−8.6 o −2.3) 0.001 −1.7 (−3.9 o 0.5) 0.12 0 ( e .) −2.2 (−4.1 o −0.2) 0.03 RF −4.3 (−10.2 o 1.6) 0.16 −0.6 (−4.7 o 3.4) 0.77 0 ( e .) −3.2 (−6.8 o 0.4) 0.08 BP −5.0 (−9.4 o −0.6) 0.03 −1.8 (−4.8 o 1.2) 0.25 0 ( e .) −3.4 (−6.1 o −0.7) 0.01 GH −3.6 (−6.6 o −0.5) 0.02 −1.6 (−3.6 o 0.5) 0.14 0 ( e .) −1.7 (−3.5 o 0.1) 0.07 VT −4.1 (−7.5 o −0.7) 0.02 −0.5 (−2.8 o 1.8) 0.68 0 ( e .) −2.9 (−5.9 o −0.9) 0.005 SF −3.4 (−6.7 o 0.03) 0.05 0.4 (−1.9 o 2.7) 0.74 0 ( e .) −2.1 (−4.2 o −0.08) 0.04 RE −0.8 (−5.5 o 3.9) 0.73 −0.7 (−3.9 o 2.5) 0.66 0 ( e .) −1.6 (−4.4 o 1.3) 0.29 MH −1.5 (−4.6 o 1.6) 0.36 1.1 (−1.0 o 3.2) 0.30 0 ( e .) −1.2 (−3.1 o 0.7) 0.23 PCS −2.3 (−3.8 o −0.8) 0.002 −0.8 (−1.8 o 0.2) 0.10 0 ( e .) −1.1 (−2.0 o −0.3) 0.01 MCS −0.3 (−2.0 o 1.3) 0.70 0.5 (−0.6 o 1.6) 0.40 0 ( e .) −0.6 (−1.6 o 0.4) 0.26 BP: bodily pain; CI: con idence in e al; GH: gene al heal h; h/d: hou s/day; HRQoL: heal h- ela ed quali y o li e; MCS: agg ega ed men al dimensions; MH: men al heal h; PCS: agg ega ed physical dimensions; PF: physical unc ion; RE: emo ional ole; RF: ole unc ion; SF: social unc ion; VT: i ali y. The da a shown a e hose co esponding o Model 2 o he linea eg ession adjus ed by sociodemog aphic a iables: age, sex, ma i al s a us (ma ied o li ing wi h a pa ne , di o ced o widowed o single), labo s a us (ac i e, e i emen and unemployed o household wo k) and educa ional le el (≤p ima y, seconda y o uni e si y). Model 3 was a linea model adjus ed o sociodemog aphic a iables: age, sex, ma i al s a us (ma ied o li ing wi h a pa ne , di o ced o widowed o single), labo s a us (ac i e, e i emen and unemployed o household wo k), educa ional le el ( ≤ p ima y, seconda y and uni e si y) and li es yle ac o s, such as smoking s a us (cu en , o me o ne e smoke ), ca eine d inks/day (mg/d), alcohol d inks/day (g/d), leisu e ime spen wa ching TV (h/wk), adhe ence o a Medi e anean die measu ed h ough a 17-i em ques ionnai e (con inuous), BMI (kg/m 2 ) and MVPA ecommenda ions (ac i e/inac i e). Model 4 was a linea model adjus ed in he same way as Model 3 and o mo bidi ies, such as hype ension (yes/no), ype 2 diabe es melli us (yes/no), seda i e ea men (yes/no), dep ession (yes/no), sleep apnea (yes/no) and ch onic obs uc i e pulmona y disease (yes/no), day ime sleep (min/day) and ea men assignmen , s a i ied by day ime sleep du a ion. In he analysis s a i ied by sex, he women who slep <6 h o ≥ 9 had a lowe sco e in he PCS (Models 1, 2 and 3), bu when adjus ed o mo bidi y, only hose women who sleep less han 6 h ha e hei PCS a ec ed. In men, only sleeping <6 h was associa ed wi h a wo se PCS in Model 1 ( Table S1). 3.2.2. Day ime Sleep Du a ion Those pa icipan s who sleep less han 7 h a nigh and ake a nap g ea e han o equal o 15 min/d show an imp o emen in MCS, while o hose who sleep 7 h o mo e a nigh , no s a is ically signi ican associa ion be ween napping and HRQoL was ound (Table 3 and Figu e 2). Model 4 was a linea model adjus ed o age, sex, ma i al s a us (ma ied o li ing wi h a pa ne , di o ced o widowed o single), labo s a us (ac i e, e i emen and unemployed o household wo k), educa ional le el ( ≤ p ima y, seconda y o uni e si y), li es yle ac o s, such as smoking s a us (cu en , o me o ne e smoke ), ca eine d inks/day (mg/d), alcohol d inks/day (g/d), leisu e ime spen wa ching TV (h/wk), adhe ence o a Medi e - anean die assessed using a 17-i em ques ionnai e (con inuous), BMI (kg/m 2 ), MVPA ecommenda ions (ac i e/inac i e), and o mo bidi ies, such as hype ension (yes/no), Nu ien s 2024,16, 2631 16 o 18 had no ole in he design o he s udy; in he collec ion, analyses o in e p e a ion o he da a; in he w i ing o he a icle o in he decision o publish he esul s. Ins i u ional Re iew Boa d S a emen : Resea ch E hics Commi ees om all ec ui men cen e s app o ed he s udy p o ocol (be ween 1 Oc obe 2013 o 31 Decembe 2016), acco ding o he e hical s anda ds o he Decla a ion o Helsinki. De ails on he p o ocol can be ound a h p://p edimedplus. com (accessed on 1 May 2024). The ial was e ospec i ely egis e ed in he In e na ional S anda d Randomized Con olled T ial egis y (ISRCTN: h p://www.is c n.com/ISRCTN89898870, accessed on 1 May 2024). In o med Consen S a emen : In o med consen was ob ained om all subjec s in ol ed in he s udy. W i en in o med consen has been ob ained om he pa ien s o publish his pape . Da a A ailabili y S a emen : The o iginal con ibu ions p esen ed in he s udy a e included in he a icle/Supplemen a y Ma e ial; u he inqui ies can be di ec ed o he co esponding au ho s. Con lic s o In e es : The au ho s decla e no con lic s o in e es . Re e ences 1. Bakou , C.; Nie o, F.J.; Pe e sen, D.J. 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[C ossRe ] Disclaime /Publishe ’s No e: The s a emen s, opinions and da a con ained in all publica ions a e solely hose o he indi idual au ho (s) and con ibu o (s) and no o MDPI and/o he edi o (s). MDPI and/o he edi o (s) disclaim esponsibili y o any inju y o people o p ope y esul ing om any ideas, me hods, ins uc ions o p oduc s e e ed o in he con en .