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Sleep to Activate Mood Promotion (STAMP)

Primary Purpose

Depression, Sleep Quality

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Re-Timer glasses
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bright Light Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Index
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.
Patient Health Questionnaire-9 Depression Scale
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.
Insomnia Severity Index Sum Scores
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.
Morningness-Eveningness Questionnaire
The morningness- eveningness categories represent the time of day when a person is at their peak alertness.

Secondary Outcome Measures

Actigraph Sleep Data: Minutes Asleep
mean nightly sleep duration for each of the two-week periods: baseline and intervention
Actigraph: Number of Awakenings
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.
Actigraph: Efficiency
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.
Fitbit Sleep Data: Sleep Duration
mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention
Fitbit Sleep Data: Night Awakenings
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.
Fitbit Sleep Data: Sleep Efficiency
Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).
Self-Reported Sleep Diary: Time at Which Participants go to Bed
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.
Self-Reported Sleep Diary: Time at Which Participants Wake up
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.
Self-Reported Sleep Diary: Sleep Quality
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).
Self-Reported Sleep Diary: Night Awakenings
mean number of night awakenings per person per night as reported in sleep diaries
Self-Reported Sleep Diary: Sleep Duration
nightly mean of length of sleep measured in minutes

Full Information

First Posted
April 6, 2015
Last Updated
April 4, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02413294
Brief Title
Sleep to Activate Mood Promotion
Acronym
STAMP
Official Title
Sleep to Activate Mood Promotion- Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Sleep Quality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright Light Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Re-Timer glasses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
two weeks after introduction of intervention
Title
Patient Health Questionnaire-9 Depression Scale
Description
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.
Time Frame
two weeks after introduction of intervention
Title
Insomnia Severity Index Sum Scores
Description
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.
Time Frame
two weeks after introduction of intervention
Title
Morningness-Eveningness Questionnaire
Description
The morningness- eveningness categories represent the time of day when a person is at their peak alertness.
Time Frame
two weeks after introduction of intervention
Secondary Outcome Measure Information:
Title
Actigraph Sleep Data: Minutes Asleep
Description
mean nightly sleep duration for each of the two-week periods: baseline and intervention
Time Frame
daily for 4 weeks- baseline and intervention period
Title
Actigraph: Number of Awakenings
Description
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.
Time Frame
daily for 4 weeks- baseline and intervention period
Title
Actigraph: Efficiency
Description
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.
Time Frame
daily for 4 weeks- baseline and intervention period
Title
Fitbit Sleep Data: Sleep Duration
Description
mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention
Time Frame
daily for 4 weeks- baseline and intervention period
Title
Fitbit Sleep Data: Night Awakenings
Description
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.
Time Frame
daily for 4 weeks- baseline and intervention period
Title
Fitbit Sleep Data: Sleep Efficiency
Description
Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).
Time Frame
daily for 4 weeks- baseline and intervention period
Title
Self-Reported Sleep Diary: Time at Which Participants go to Bed
Description
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.
Time Frame
daily for 4 weeks- baseline and intervention period to be compared
Title
Self-Reported Sleep Diary: Time at Which Participants Wake up
Description
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.
Time Frame
daily for 4 weeks- baseline and intervention period to be compared
Title
Self-Reported Sleep Diary: Sleep Quality
Description
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).
Time Frame
daily for 4 weeks- baseline and intervention period to be compared
Title
Self-Reported Sleep Diary: Night Awakenings
Description
mean number of night awakenings per person per night as reported in sleep diaries
Time Frame
daily for 4 weeks- baseline and intervention period to be compared
Title
Self-Reported Sleep Diary: Sleep Duration
Description
nightly mean of length of sleep measured in minutes
Time Frame
daily for 4 weeks- baseline and intervention period to be compared

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda N Leggett, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Sleep to Activate Mood Promotion

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