Sleep to Activate Mood Promotion

NCT ID: NCT02413294

Last Updated: 2017-04-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-03-31

Brief Summary

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The investigators are aiming to examine the acceptability and feasibility of a portable bright light therapy instrument to improve sleep disturbance in a preventive intervention for depression. The investigators will conduct an intervention that trials the use of bright light glasses called "re-timers" as a preventive intervention in older adults with sleep disturbance and subsyndromal symptoms of depression.

Detailed Description

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Conditions

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Depression Sleep Quality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bright Light Intervention

Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.

Group Type EXPERIMENTAL

Re-Timer glasses

Intervention Type DEVICE

Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study.

Interventions

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Re-Timer glasses

Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 65 years of age or older
* 6 or greater on the Pittsburgh Sleep Quality Index
* A score of 5 to 9 on the Patient Health Questionnaire-9 Depression Scale

Exclusion Criteria

* Active suicidal ideation
* Presence of mania or bipolar disorder
* Presence of an eye disease
* Prescription of a photosensitizing medication
* Having previously had eye surgery
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Amanda Leggett

Postdoctoral Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda N Leggett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00094645

Identifier Type: -

Identifier Source: org_study_id

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