SleepNCT02926157
Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
A study testing Life Style and Sleep Intervention in people with Sleep and Aging, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- What is being tested?
- Life Style and Sleep Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
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.
Read the 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).
- Being tested
- Life Style and Sleep Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Style and Sleep InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Life Style and Sleep Group | Experimental | 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. Receives: Behavioral: Life Style and Sleep Intervention |
| Wait-list Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (4)
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
Measured: Baseline, 3 months, and 6 months
Change from baseline in self-reported sleep quality as measured by the Pittsburgh Sleep Quality Index at 3 and 6 months
Measured: Baseline, 3 months, and 6 months
Change from baseline in physical activity levels as measured by Motion Watch 8 at 3 and 6 months
Measured: Baseline, 3 months, and 6 months
Change from baseline in self-reported physical activity levels as measured by CHAMPS physical activity questionnaire each month
Measured: Monthly, from baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, PhD, Principal investigator, University of British ColumbiaGlenn Landry, PhD, Principal investigator, University of British ColumbiaLinda Li, PhD, Principal investigator, University of British ColumbiaCatherine Chan, MPT, Principal investigator, University of British ColumbiaJohn Best, PhD, Principal investigator, University of British ColumbiaCindy Barha, PhD, Principal investigator, University of British ColumbiaJennifer Davis, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926157
- Sponsor's protocol ID
- H16-01029
- Status last verified
- May 2019
- First submitted
- 21 Sep 2016
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balbim GM, Boa Sorte Silva NC, Falck RS, Kramer AF, Voss MW, Liu-Ambrose T. 24-hour activity cycle behaviors and gray matter volume in mild cognitive impairment. Alzheimers Dement. 2025 Jul;21(7):e70496. doi: 10.1002/alz.70496.
PubMed 40693459Falck 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.
PubMed 32444553Falck 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.
PubMed 30119694
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT02926157
- Acronym / sponsor ID
- H16-01029
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life Style and Sleep Group | Experimental | Behavioral: Life Style and Sleep InterventionParticipants 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. |
| Wait-list Control | No intervention | –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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Style and Sleep Intervention | Behavioural | Life Style and Sleep Group |
Primary outcome
Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
4 secondary outcomes
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
Time frame: Baseline, 3 months, and 6 months
Change from baseline in self-reported sleep quality as measured by the Pittsburgh Sleep Quality Index at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in physical activity levels as measured by Motion Watch 8 at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in self-reported physical activity levels as measured by CHAMPS physical activity questionnaire each month
Time frame: Monthly, from baseline through 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Derived from this study: PubMed 40693459Balbim GM, Boa Sorte Silva NC, Falck RS, Kramer AF, Voss MW, Liu-Ambrose T. 24-hour activity cycle behaviors and gray matter volume in mild cognitive impairment. Alzheimers Dement. 2025 Jul;21(7):e70496. doi: 10.1002/alz.70496.
- Derived from this study: PubMed 32444553Falck 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.
- Derived from this study: PubMed 30119694Falck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Liu-Ambrose, PhD principal investigator
University of British Columbia
Glenn Landry, PhD principal investigator
University of British Columbia
Linda Li, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Style and Sleep Intervention in people with Sleep and Aging, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926157, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.