Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-01-24 @ 6:19 PM
Study NCT ID:
NCT02926157
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2016-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2016-09-21', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sleep', 'Aging']}, 'referencesModule': {'references': [{'pmid': '40693459', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32444553', 'type': 'DERIVED', '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.'}, {'pmid': '30119694', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sleep complaints\n* Community-dwelling (not in a long term care facility)\n* Read, write, and speak English\n* Able to walk independently\n* In sufficient health to participate in regular physical activity\n\nExclusion Criteria:\n\n* Diagnosis of obstructive sleep apnea\n* Receiving continuous positive air pressure (CPAP) treatment\n* Diagnosed with dementia of any type\n* At high risk for cardiac complications during physical activity or unable to self-regulate activity or understand recommended activity level\n* Have a clinically important peripheral neuropathy or sever musculoskeletal or joint disease that impairs mobility'}, 'identificationModule': {'nctId': 'NCT02926157', 'briefTitle': 'Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Buying Time: Improving Sleep to Promote Cognitive Function in Older Adults', 'orgStudyIdInfo': {'id': 'H16-01029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Life Style and Sleep Group', 'description': '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.', 'interventionNames': ['Behavioral: Life Style and Sleep Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list Control', 'description': '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.'}], 'interventions': [{'name': 'Life Style and Sleep Intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Life Style and Sleep Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'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', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Teresa Liu-Ambrose', 'investigatorAffiliation': 'University of British Columbia'}}}}