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Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults

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ClinicalTrials.gov Identifier: NCT02926157
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Teresa Liu-Ambrose, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Sleep Aging Behavioral: Life Style and Sleep Intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 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.
Behavioral: Life Style and Sleep Intervention
No Intervention: 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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926157


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Teresa Liu-Ambrose, PhD University of British Columbia
Principal Investigator: Glenn Landry, PhD University of British Columbia
Principal Investigator: Linda Li, PhD University of British Columbia
Principal Investigator: Catherine Chan, MPT University of British Columbia
Principal Investigator: John Best, PhD University of British Columbia
Principal Investigator: Cindy Barha, PhD University of British Columbia
Principal Investigator: Jennifer Davis, PhD University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Teresa Liu-Ambrose, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02926157     History of Changes
Other Study ID Numbers: H16-01029
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019