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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02926157
Other study ID # H16-01029
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date December 2018

Study information

Verified date May 2019
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 older adults.


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).


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Life Style and Sleep Intervention


Locations

Country Name City State
Canada University of British Columbia Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months Baseline, 3 months, and 6 months
Secondary 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 Baseline, 3 months, and 6 months
Secondary Change from baseline in self-reported sleep quality as measured by the Pittsburgh Sleep Quality Index at 3 and 6 months Baseline, 3 months, and 6 months
Secondary Change from baseline in physical activity levels as measured by Motion Watch 8 at 3 and 6 months Baseline, 3 months, and 6 months
Secondary Change from baseline in self-reported physical activity levels as measured by CHAMPS physical activity questionnaire each month Monthly, from baseline through 6 months
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