- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02835261
Indvirkningen af søvnbegrænsning hos kvinder
Indvirkning af søvnrestriktion på kardiometabolske risikofaktorer hos kvinder før eller efter overgangsalderen
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dette projekt er finansieret af American Heart Association Go Red for Women Strategically Focused Research Network (SFRN). Dette SFRN omfatter to separate projekter: Clinical Science Project (PI, St-Onge) og Basic Science Project (PI, Jelic). Kvinder er tilmeldt projektet Clinical Science og får mulighed for at deltage i Basic Science-projektet. Hvert projekt (klinisk og grundlæggende) har sine egne separate primære og sekundære resultater. For Clinical Science-projektet er primære resultater glukosetolerance og ambulant og kontorblodtryk; og sekundære resultater er kropssammensætning og cirkulerende inflammatoriske markører. For Basic Science-projektet er de primære resultater flowmedieret dilatation af arterien brachialis (FMD) og sekundære resultater er endotelcelleoxidativ stress og inflammation. Resultaterne af disse to projekter vil blive rapporteret i separate og kombinerede publikationer.
Dette studie vil være et randomiseret, crossover, ambulant søvnrestriktionsstudie (SR) med 2 faser på 6 uger hver, med en 6 ugers udvaskningsperiode mellem faserne. Søvnvarigheden i hver fase vil være deltagerens faste senge- og vågnetider under den sædvanlige søvnfase (HS) og HS minus 1,5 time i SR-fasen. Under HS-fasen vil deltagerne blive bedt om at følge en fast sengetidsrutine baseret på deres screeningssøvnskema. Under SR-fasen vil deltagerne blive bedt om at holde deres sædvanlige vågnetid konstant, men udskyde deres sengetid for at opnå en reduktion på 1,5 timer i den samlede søvntid.
På den første dag af hver undersøgelsesfase (baseline) vil deltagerne komme til forskningscentret om morgenen efter en nat, 12 timers faste. Deltagerne vil få taget antropometriske målinger og vil derefter blive bragt til Radiologiafdelingen for at gennemgå magnetisk resonansbilleddannelse (MRI) scanning for at vurdere kropssammensætning. Flow-medieret dilatation vil blive udført i det kardiovaskulære ultralydslaboratorium efterfulgt af endotelcellehøst (Basic Science-projekt). En prøve af celler, der beklæder blodkarret (underarmsvenen), vil blive taget for at vurdere endotelfunktionen. Kvinder vil gennemgå en oral glukosetolerancetest (Clinical Science project). Der vil blive taget blodprøver til hormonmålinger (insulin, kortisol). Deltagerne begynder den faste sengetid den aften. Disse baseline-målinger vil blive gentaget ved slutpunktet 6 uger senere. Kropsvægt og taljeomkreds vil blive målt ugentligt, og fastende blodprøver vil blive taget i uge 3 og 4 under overholdelseskontrolbesøg.
For at verificere, at deltagerne overholder søvnprotokollen, vil de blive bedt om at føre en søvndagbog og bære en aktivitetsmonitor 24 timer i døgnet. Deltagerne vil bære en actigraph GT3X+ på deres håndled, som vil tjene til at spore deres søvnvarighed, søvntiming og fysisk aktivitet. To uger før randomisering og under udvaskningsperioden vil deltagerne også bære actigraph-uret og føre en søvndagbog for at verificere søvnvarighed og søvn-vågen-tidsplan. Ud over at opnå en gennemsnitlig søvn på 7-9 timer/nat, ved håndledsaktigrafi, vil deltagerne kun blive tilmeldt, hvis de opnår 7 timers søvn i mindst 10 af de 14 nætter med screening og har <4 nætter med <6 timer af søvn. På tidspunktet for randomisering vil der blive udført en uringraviditetstest og lægemiddelscreening. Deltagerne vil blive bedt om at afholde sig fra koffein og alkohol i 24 timer før start. Mellem undersøgelsens faser, hvis deltagerne ikke er vendt tilbage til baseline søvnmønstre inden for 6 ugers udvaskningsperioden, vil der blive givet en yderligere 2-4 ugers udvaskningsperiode. Denne udvaskningslængde vil sikre, at kvinder er i samme fase af deres menstruationscyklus ved starten af hver forsøgsfase.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10032
- New York Obesity Nutrition Research Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Alder 20-75 år
- Alle race/etniske grupper
- Body mass index 18,5-34,9 kg/m2
- Sov 7-9 timer i sengen/nat uden lur i dagtimerne
- Normal score på:
Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Aftenness, Three Factor Eating Questionnaire
Ekskluderingskriterier:
- Rygere (enhver cigaretter eller tidligere ryger <3 år)
- Neurologisk, medicinsk eller psykiatrisk lidelse
- Diabetikere
- Regelmæssig brug af medicin eller kosttilskud
- Spise- og/eller søvnforstyrrelser
- Kontraindikationer for MR-scanning
- Rejs på tværs af tidszoner inden for 4 uger
- Historie om stof- og alkoholmisbrug
- Skifteholdsarbejder (eller roterende skifteholdsarbejder)
- Koffeinindtag >300 mg/d
- Brug af oral prævention eller hormonbehandling
- Operatører af tungt udstyr
- Kommercielle langdistancechauffører.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Sædvanlig søvn (HS)
Under HS-fasen vil deltagerne blive bedt om at følge en fast sengetidsrutine baseret på deres screeningssøvnskema.
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Eksperimentel: Søvnbegrænsning (SR)
Under SR-fasen vil deltagerne blive bedt om at holde deres sædvanlige vågnetid konstant, men udskyde deres sengetid for at opnå en reduktion på 1,5 time i den samlede søvntid.
En forsinkelse i sengetider blev valgt i stedet for at fremskynde opvågningstiden, fordi den mest afspejler forskelle i søvntidsadfærd mellem kortere og normale sovende.
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Mild søvnbegrænsning (-1,5 t/nat) over en periode på 6 uger
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring i glukosetolerance
Tidsramme: baseline til 6 uger
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Oral glukosetolerancetest
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baseline til 6 uger
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Ændring i blodtryk
Tidsramme: baseline til 6 uger
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24-timers ambulant blodtryk; ugentlig kontorblodtryk
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baseline til 6 uger
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Flow-medieret dilatation
Tidsramme: baseline til 6 uger
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Slutpunkt MKS
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baseline til 6 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ændring i fedt
Tidsramme: baseline til 6 uger
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Kropssammensætning målt ved magnetisk resonansbilleddannelse
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baseline til 6 uger
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Ændring i fysisk aktivitetsniveau
Tidsramme: baseline til 6 uger
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Tid i forskellige adfærdsformer: stillesiddende, let, moderat, moderat til kraftig fysisk aktivitet
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baseline til 6 uger
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C-reaktivt protein
Tidsramme: Uge 0, 3, 4 og 6
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Inflammatoriske markører
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Uge 0, 3, 4 og 6
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Interleukin-6
Tidsramme: Uge 0, 3, 4 og 6
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Inflammatoriske markører
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Uge 0, 3, 4 og 6
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Tumornekrosefaktor
Tidsramme: Uge 0, 3, 4 og 6
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Inflammatoriske markører
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Uge 0, 3, 4 og 6
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T-cellers reaktivitet over for viral belastning
Tidsramme: Uge 0 og 6
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Immune markører
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Uge 0 og 6
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Kolesterol
Tidsramme: Uge 0 og 6
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Total, lav-densitet og high-density lipoprotein
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Uge 0 og 6
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Triglycerider
Tidsramme: Uge 0 og 6
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Lipidæmi
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Uge 0 og 6
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Endotelcelle oxidativ stress
Tidsramme: Baseline til 6 uger
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redoxfølsom fluorogen probe-fluorescensintensitet
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Baseline til 6 uger
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Endotelbetændelse
Tidsramme: baseline til 6 uger
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NF-KB nuklear fluorescens område
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baseline til 6 uger
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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NIH Toolbox® til vurdering af neurologisk og adfærdsmæssig funktion (NIH Toolbox)
Tidsramme: Uge 0 og 6
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Neuro-adfærdsvurderinger: kognition, motor, sansning rå score
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Uge 0 og 6
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marie-Pierre St-Onge, PhD, Columbia University-New York Obesity Nutrition Research Center
Publikationer og nyttige links
Generelle publikationer
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