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

May 7, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Monthly, from baseline through 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • H16-01029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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