Clinical trial NCT02926157: Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
Official title: Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Aging
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 96
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: 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
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in self-reported sleep quality as measured by the Pittsburgh Sleep Quality Index at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in physical activity levels as measured by Motion Watch 8 at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from baseline in self-reported physical activity levels as measured by CHAMPS physical activity questionnaire each month
timeFrame: Monthly, from baseline through 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Teresa Liu-Ambrose, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Glenn Landry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Linda Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Catherine Chan, MPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: John Best, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Cindy Barha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Jennifer Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.