Sleep to Activate Mood Promotion

NCT02413294 | Completed Results

• 1 other identifier: HUM00094645
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Sleep Quality

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Actigraph Sleep Data: Minutes Asleep

  daily for 4 weeks- baseline and intervention period

• Actigraph: Number of Awakenings

  daily for 4 weeks- baseline and intervention period

• Actigraph: Efficiency

  daily for 4 weeks- baseline and intervention period

• Fitbit Sleep Data: Sleep Duration

  daily for 4 weeks- baseline and intervention period

• Fitbit Sleep Data: Night Awakenings

  daily for 4 weeks- baseline and intervention period

Study Arms (1)

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.

Device: Re-Timer glasses

Interventions

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.

Bright Light Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• or greater on the Pittsburgh Sleep Quality Index
• A score of 5 to 9 on the Patient Health Questionnaire-9 Depression Scale

You may not qualify if:

• Active suicidal ideation
• Presence of mania or bipolar disorder
• Presence of an eye disease
• Prescription of a photosensitizing medication
• Having previously had eye surgery

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Amanda Leggett
• Organization: University of Michigan

leggetta@med.umich.edu

734-232-0538

Study Officials

• Amanda N Leggett, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 9, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-04

Locations

US (1)