Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
7. maj 2019 opdateret af: Teresa Liu-Ambrose, University of British Columbia
The purpose of this study is to investigate whether a comprehensive group education combined with a lifestyle "activation" program that includes (a) sleep hygiene course, (b) physical activity promotion, and (c) bright light therapy, can improve both sleep quality and cognitive function among 96 community-dwelling older adults.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
96 community-dwelling older adults with sleep complaints will be randomized into either a 6-month life style and sleep activation intervention program or a waitlist control group (participants in this group will be offered an abbreviated version of the program upon completion of the 6 month study).
There are 3 measurement sessions to measure cognition, sleep, and physical activity at the onset of the study, the midway (3 month) point, and completion (at 6 months).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
96
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z3
- University of British Columbia
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 85 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Sleep complaints
- Community-dwelling (not in a long term care facility)
- Read, write, and speak English
- Able to walk independently
- In sufficient health to participate in regular physical activity
Exclusion Criteria:
- Diagnosis of obstructive sleep apnea
- Receiving continuous positive air pressure (CPAP) treatment
- Diagnosed with dementia of any type
- At high risk for cardiac complications during physical activity or unable to self-regulate activity or understand recommended activity level
- Have a clinically important peripheral neuropathy or sever musculoskeletal or joint disease that impairs mobility
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Life Style and Sleep Group
Participants randomized into this group will undergo a 4 week sleep hygiene course (classes 1x/week for 1.5 hours), followed by a 20 week lifestyle activation program.
During the 20 week lifestyle activation program, participants wear a Fit Bit and receive a call from a fitness professional every other week for motivation and recommendations, and receive a bright light therapy program from a sleep expert based on their initial sleep results at the baseline measurement session.
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Ingen indgriben: Wait-list Control
Participants randomized into this group will complete all measurement sessions.
After completion of the final measurement session (6 months), participants will be offered an abbreviated version of the Life Style and Sleep Group intervention including the sleep hygiene course, consultation with sleep expert to go over individual sleep patterns and be given recommendations, along with physical activity recommendations from a fitness expert.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months
Tidsramme: Baseline, 3 months, and 6 months
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Baseline, 3 months, and 6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 3 and 6 months
Tidsramme: Baseline, 3 months, and 6 months
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Baseline, 3 months, and 6 months
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Change from baseline in self-reported sleep quality as measured by the Pittsburgh Sleep Quality Index at 3 and 6 months
Tidsramme: Baseline, 3 months, and 6 months
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Baseline, 3 months, and 6 months
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Change from baseline in physical activity levels as measured by Motion Watch 8 at 3 and 6 months
Tidsramme: Baseline, 3 months, and 6 months
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Baseline, 3 months, and 6 months
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Change from baseline in self-reported physical activity levels as measured by CHAMPS physical activity questionnaire each month
Tidsramme: Monthly, from baseline through 6 months
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Monthly, from baseline through 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Teresa Liu-Ambrose, PhD, University of British Columbia
- Ledende efterforsker: Glenn Landry, PhD, University of British Columbia
- Ledende efterforsker: Linda Li, PhD, University of British Columbia
- Ledende efterforsker: Catherine Chan, MPT, University of British Columbia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Falck RS, Davis JC, Best JR, Chan PCY, Li LC, Wyrough AB, Bennett KJ, Backhouse D, Liu-Ambrose T. Effect of a Multimodal Lifestyle Intervention on Sleep and Cognitive Function in Older Adults with Probable Mild Cognitive Impairment and Poor Sleep: A Randomized Clinical Trial. J Alzheimers Dis. 2020;76(1):179-193. doi: 10.3233/JAD-200383.
- Falck RS, Davis JC, Best JR, Li LC, Chan PCY, Wyrough AB, Landry GJ, Liu-Ambrose T. Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment. Trials. 2018 Aug 17;19(1):445. doi: 10.1186/s13063-018-2837-7.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2016
Primær færdiggørelse (Faktiske)
1. december 2018
Studieafslutning (Faktiske)
1. december 2018
Datoer for studieregistrering
Først indsendt
21. september 2016
Først indsendt, der opfyldte QC-kriterier
4. oktober 2016
Først opslået (Skøn)
6. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- H16-01029
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .