Sleep to Activate Mood Promotion

Depression Clinical Trial

— STAMP  

Official title:

Sleep to Activate Mood Promotion- Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413294
• Other study ID #: HUM00094645
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: April 4, 2017
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Sleep Quality

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	two weeks after introduction of intervention
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.	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.	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.	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	daily for 4 weeks- baseline and intervention period
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.	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.	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	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.	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).	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.	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.	daily for 4 weeks- baseline and intervention period to be compared
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).	daily for 4 weeks- baseline and intervention period to be compared
Secondary	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
Secondary	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