- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413294
Sleep to Activate Mood Promotion (STAMP)
April 4, 2017 updated by: Amanda Leggett, University of Michigan
Sleep to Activate Mood Promotion- Intervention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
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
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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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 and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index
Time Frame: two weeks after introduction of intervention
|
The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.
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two weeks after introduction of intervention
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Patient Health Questionnaire-9 Depression Scale
Time Frame: two weeks after introduction of intervention
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The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.
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two weeks after introduction of intervention
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Insomnia Severity Index Sum Scores
Time Frame: two weeks after introduction of intervention
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The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28.
A score of 15 or higher is indicative of clinical insomnia.
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two weeks after introduction of intervention
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Morningness-Eveningness Questionnaire
Time Frame: two weeks after introduction of intervention
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The morningness- eveningness categories represent the time of day when a person is at their peak alertness.
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two weeks after introduction of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actigraph Sleep Data: Minutes Asleep
Time Frame: daily for 4 weeks- baseline and intervention period
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mean nightly sleep duration for each of the two-week periods: baseline and intervention
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daily for 4 weeks- baseline and intervention period
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Actigraph: Number of Awakenings
Time Frame: daily for 4 weeks- baseline and intervention period
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Actigraphy counts awakenings by using an accelerometer to assess motion during the night.
The number of awakenings is the mean nightly number of awakenings during each of the two-week periods: baseline and intervention.
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daily for 4 weeks- baseline and intervention period
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Actigraph: Efficiency
Time Frame: daily for 4 weeks- baseline and intervention period
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Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).
The mean for each of the two-week periods: baseline and intervention, is calculated.
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daily for 4 weeks- baseline and intervention period
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Fitbit Sleep Data: Sleep Duration
Time Frame: daily for 4 weeks- baseline and intervention period
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mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention
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daily for 4 weeks- baseline and intervention period
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Fitbit Sleep Data: Night Awakenings
Time Frame: daily for 4 weeks- baseline and intervention period
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mean nightly awakenings for each of the two week periods: baseline and intervention.
Similar to the actigraph the Fitbit counts awakenings through an accelerometer which measures motion.
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daily for 4 weeks- baseline and intervention period
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Fitbit Sleep Data: Sleep Efficiency
Time Frame: daily for 4 weeks- baseline and intervention period
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Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).
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daily for 4 weeks- baseline and intervention period
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Self-Reported Sleep Diary: Time at Which Participants go to Bed
Time Frame: daily for 4 weeks- baseline and intervention period to be compared
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Bed time represents the moment in time at which participants went to bed, measured on a revised clock where 6pm = 18, Midnight = 24 and 6am =30.
Time between actual hours is calculated on a decimal basis, so an additional 6 minutes = .1.
This revised clock is necessary in order to make means work properly in the nighttime hours.
Otherwise, averaging between a 10pm bedtime and a 2am bedtime would give the impossible, inaccurate mean of being in the daytime between those two numbers.
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daily for 4 weeks- baseline and intervention period to be compared
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Self-Reported Sleep Diary: Time at Which Participants Wake up
Time Frame: daily for 4 weeks- baseline and intervention period to be compared
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Wake time represents the moment in time at which participants awaken.
Time between actual hours is calculated on a decimal basis so an additional 6 minutes = .1.
so that 7.5 represents 7:30 a.m. and 7.8 represents 7:48 a.m.
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daily for 4 weeks- baseline and intervention period to be compared
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Self-Reported Sleep Diary: Sleep Quality
Time Frame: daily for 4 weeks- baseline and intervention period to be compared
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sleep quality is a participants' mean self-report for each of the two week periods: baseline and intervention.
Sleep quality is reported for each night on a scale of 0 (very poor) to 4 (very good).
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daily for 4 weeks- baseline and intervention period to be compared
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Self-Reported Sleep Diary: Night Awakenings
Time Frame: daily for 4 weeks- baseline and intervention period to be compared
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mean number of night awakenings per person per night as reported in sleep diaries
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daily for 4 weeks- baseline and intervention period to be compared
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Self-Reported Sleep Diary: Sleep Duration
Time Frame: daily for 4 weeks- baseline and intervention period to be compared
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nightly mean of length of sleep measured in minutes
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daily for 4 weeks- baseline and intervention period to be compared
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda N Leggett, PhD, University of Michigan
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
April 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 6, 2015
First Submitted That Met QC Criteria
April 8, 2015
First Posted (Estimate)
April 9, 2015
Study Record Updates
Last Update Posted (Actual)
April 7, 2017
Last Update Submitted That Met QC Criteria
April 4, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00094645
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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