Sleep to Activate Mood Promotion

Study Overview
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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.

Official Title
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Sleep to Activate Mood Promotion- Intervention

Conditions
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Depression, Sleep Quality

Intervention / Treatment
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* Device: Re-Timer glasses


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright Light Intervention<br>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. | Device: Re-Timer glasses<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two weeks after introduction of intervention | 
| 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. | two weeks after introduction of intervention | 
| 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. | two weeks after introduction of intervention | 
| Morningness-Eveningness Questionnaire | The morningness- eveningness categories represent the time of day when a person is at their peak alertness. | two weeks after introduction of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actigraph Sleep Data: Minutes Asleep | mean nightly sleep duration for each of the two-week periods: baseline and intervention | daily for 4 weeks- baseline and intervention period | 
| 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. | daily for 4 weeks- baseline and intervention period | 
| 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. | daily for 4 weeks- baseline and intervention period | 
| Fitbit Sleep Data: Sleep Duration | mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention | daily for 4 weeks- baseline and intervention period | 
| 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. | daily for 4 weeks- baseline and intervention period | 
| 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). | daily for 4 weeks- baseline and intervention period | 
| 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. | daily for 4 weeks- baseline and intervention period to be compared | 
| 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. | daily for 4 weeks- baseline and intervention period to be compared | 
| 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). | daily for 4 weeks- baseline and intervention period to be compared | 
| Self-Reported Sleep Diary: Night Awakenings | mean number of night awakenings per person per night as reported in sleep diaries | daily for 4 weeks- baseline and intervention period to be compared | 
| Self-Reported Sleep Diary: Sleep Duration | nightly mean of length of sleep measured in minutes | daily for 4 weeks- baseline and intervention period to be compared |