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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Re-Timer glasses | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda N Leggett, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline measures are given for the study sample that completed study procedures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | two weeks after introduction of intervention |
|
Up to 29 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Leggett | University of Michigan | 734-232-0538 | leggetta@med.umich.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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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.
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patient Health Questionnaire-9 | 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Insomnia Severity Index | 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. Data for all 11 participants is provided at two baseline time points: prior to wearing a monitor at all, and after two weeks of wearing a monitoring device, prior to use of ReTimer glasses | Mean | Standard Deviation | units on a scale |
|
| Morningness/Eveningness Questionnaire | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | two weeks after introduction of intervention |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | two weeks after introduction of intervention |
|
|
|
|
| Primary | Morningness-Eveningness Questionnaire | The morningness- eveningness categories represent the time of day when a person is at their peak alertness. | Posted | Count of Participants | Participants | two weeks after introduction of intervention |
|
|
|
|
| Secondary | Actigraph Sleep Data: Minutes Asleep | mean nightly sleep duration for each of the two-week periods: baseline and intervention | Posted | Mean | Standard Deviation | minutes | daily for 4 weeks- baseline and intervention period |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | count of awakenings | daily for 4 weeks- baseline and intervention period |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of time in bed spent asleep | daily for 4 weeks- baseline and intervention period |
|
|
|
|
| Secondary | Fitbit Sleep Data: Sleep Duration | mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention | Posted | Mean | Standard Deviation | Minutes asleep | daily for 4 weeks- baseline and intervention period |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | count of night awakenings | daily for 4 weeks- baseline and intervention period |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | percentage of time in bed spent asleep | daily for 4 weeks- baseline and intervention period |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hour (military time) | daily for 4 weeks- baseline and intervention period to be compared |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hour (military time) | daily for 4 weeks- baseline and intervention period to be compared |
|
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|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | daily for 4 weeks- baseline and intervention period to be compared |
|
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|
|
| Secondary | Self-Reported Sleep Diary: Night Awakenings | mean number of night awakenings per person per night as reported in sleep diaries | Posted | Mean | Standard Deviation | Number of night awakenings | daily for 4 weeks- baseline and intervention period to be compared |
|
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|
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| Secondary | Self-Reported Sleep Diary: Sleep Duration | nightly mean of length of sleep measured in minutes | Posted | Mean | Standard Deviation | Minutes asleep | daily for 4 weeks- baseline and intervention period to be compared |
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| 0 |
| 12 |
| 0 |
| 12 |
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| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |