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Completed

NCT Number: NCT02413294

Sleep to Activate Mood Promotion

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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Key information

Conditions

Depression Behavior Behavioral Symptoms Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: two weeks after introduction of intervention

    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.

  2. Patient Health Questionnaire-9 Depression Scale

    Time frame: two weeks after introduction of intervention

    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.

  3. Insomnia Severity Index Sum Scores

    Time frame: two weeks after introduction of intervention

    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.

  4. Morningness-Eveningness Questionnaire

    Time frame: two weeks after introduction of intervention

    The morningness- eveningness categories represent the time of day when a person is at their peak alertness.

Secondary outcomes

  1. Actigraph Sleep Data: Minutes Asleep

    Time frame: daily for 4 weeks- baseline and intervention period

    mean nightly sleep duration for each of the two-week periods: baseline and intervention

  2. Actigraph: Number of Awakenings

    Time frame: daily for 4 weeks- baseline and intervention period

    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.

  3. Actigraph: Efficiency

    Time frame: daily for 4 weeks- baseline and intervention period

    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.

  4. Fitbit Sleep Data: Sleep Duration

    Time frame: daily for 4 weeks- baseline and intervention period

    mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention

  5. Fitbit Sleep Data: Night Awakenings

    Time frame: daily for 4 weeks- baseline and intervention period

    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.

  6. Fitbit Sleep Data: Sleep Efficiency

    Time frame: daily for 4 weeks- baseline and intervention period

    Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).

  7. Self-Reported Sleep Diary: Time at Which Participants go to Bed

    Time frame: daily for 4 weeks- baseline and intervention period to be compared

    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.

  8. Self-Reported Sleep Diary: Time at Which Participants Wake up

    Time frame: daily for 4 weeks- baseline and intervention period to be compared

    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.

  9. Self-Reported Sleep Diary: Sleep Quality

    Time frame: daily for 4 weeks- baseline and intervention period to be compared

    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).

  10. Self-Reported Sleep Diary: Night Awakenings

    Time frame: daily for 4 weeks- baseline and intervention period to be compared

    mean number of night awakenings per person per night as reported in sleep diaries

  11. Self-Reported Sleep Diary: Sleep Duration

    Time frame: daily for 4 weeks- baseline and intervention period to be compared

    nightly mean of length of sleep measured in minutes

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Sleep to Activate Mood Promotion- Intervention

Acronym: STAMP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 9, 2015
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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