Self-Management of Sleep Among Older Adults

NCT ID: NCT03837249

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2020-01-30

Brief Summary

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The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.

Detailed Description

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Conditions

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Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparative control - 3 group
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
One group - personal sleep monitoring data with-held then provided after the intervention period.

Study Groups

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Passive Personal Sleep Monitoring

Wears personal sleep monitor but does not actively self-monitor (will have access to the sleep data and self-monitoring after 4 weeks).

Group Type PLACEBO_COMPARATOR

Personal Sleep Monitoring

Intervention Type DEVICE

Wearable Sleep Self-Monitoring Device (Actigraphy)

Individual Personal Sleep Monitoring

Wears personal sleep monitor and actively self-monitoring sleep and using data to self-manage sleep.

Group Type ACTIVE_COMPARATOR

Personal Sleep Monitoring

Intervention Type DEVICE

Wearable Sleep Self-Monitoring Device (Actigraphy)

Socially Supported Sleep Monitoring

Wears a personal sleep monitor, actively self-monitoring using sleep data to self-manage sleep and shares data for supportive self-management.

Group Type ACTIVE_COMPARATOR

Personal Sleep Monitoring

Intervention Type DEVICE

Wearable Sleep Self-Monitoring Device (Actigraphy)

Interventions

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Personal Sleep Monitoring

Wearable Sleep Self-Monitoring Device (Actigraphy)

Intervention Type DEVICE

Other Intervention Names

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Personal Sleep Monitor

Eligibility Criteria

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Inclusion Criteria

* 65 years or older
* Self-report difficulty sleeping
* Willingness to wear the PSMD for four weeks
* Cognitive abilities (Mini Cog of 5 or above).

Exclusion Criteria

* Under the age of 65
* Presence of known sleep disorders
* Severe cognitive or neurosensory impairment
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Amherst

OTHER

Sponsor Role lead

Responsible Party

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Raeann G LeBlanc

Assistant Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raeann G LeBlanc, PhD, DNP

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Amherst

Locations

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University of Massachusetts

Amherst, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2018-5225

Identifier Type: -

Identifier Source: org_study_id

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