DepressionSTAMPNCT02413294

Sleep to Activate Mood Promotion

A study testing Re-Timer glasses in people with Depression and Sleep Quality, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Depression, Sleep Quality
What is being tested?: Re-Timer glasses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Apr 2015to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Sleep to Activate Mood Promotion- Intervention

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
Being tested: Re-Timer glasses
Medical subject headings: Depression, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Re-Timer glassesDevice
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.

Study groups in NCT02413294
Study group	Role	What they receive
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. Receives: Device: Re-Timer glasses

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: two weeks after introduction of intervention

Secondary outcomes (11)

Actigraph Sleep Data: Minutes Asleep
mean nightly sleep duration for each of the two-week periods: baseline and intervention
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: daily for 4 weeks- baseline and intervention period to be compared

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Mar 2016

First posted9 Apr 2015 (estimated)
Study startApr 2015
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02413294
Sponsor's protocol ID: HUM00094645
Acronym: STAMP
Status last verified: Apr 2017
First submitted: 6 Apr 2015
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep to Activate Mood Promotion- Intervention
ClinicalTrials.gov ID: NCT02413294
Acronym / sponsor ID: STAMP / HUM00094645
Conditions: Depression, Sleep Quality
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Apr 2015
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 9 Apr 2015 (estimated)
Results: Posted 7 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bright Light Intervention	Experimental	Device: Re-Timer glassesBefore 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Re-Timer glassesParticipants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study.	Device	Bright Light Intervention

Primary outcome

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.
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.
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.
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.

11 secondary outcomes

Actigraph Sleep Data: Minutes Asleep
Time frame: daily for 4 weeks- baseline and intervention period
Actigraph: Number of Awakenings
Time frame: daily for 4 weeks- baseline and intervention period
Actigraph: Efficiency
Time frame: daily for 4 weeks- baseline and intervention period
Fitbit Sleep Data: Sleep Duration
Time frame: daily for 4 weeks- baseline and intervention period
Fitbit Sleep Data: Night Awakenings
Time frame: daily for 4 weeks- baseline and intervention period
Fitbit Sleep Data: Sleep Efficiency
Time frame: daily for 4 weeks- baseline and intervention period
Self-Reported Sleep Diary: Time at Which Participants go to Bed
Time frame: daily for 4 weeks- baseline and intervention period to be compared
Self-Reported Sleep Diary: Time at Which Participants Wake up
Time frame: daily for 4 weeks- baseline and intervention period to be compared
Self-Reported Sleep Diary: Sleep Quality
Time frame: daily for 4 weeks- baseline and intervention period to be compared
Self-Reported Sleep Diary: Night Awakenings
Time frame: daily for 4 weeks- baseline and intervention period to be compared
Self-Reported Sleep Diary: Sleep Duration
Time frame: daily for 4 weeks- baseline and intervention period to be compared

Results and safety

Results posted to the registry on 7 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bright Light Intervention	12	11

Primary outcome: Pittsburgh Sleep Quality Index

Time frame: two weeks after introduction of intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	Bright Light Intervention n = 11
Value	7.0 (3.4)

Bright Light Intervention: p = 0.37, Paired T test, 2-sided

Primary outcome: Patient Health Questionnaire-9 Depression Scale

Time frame: two weeks after introduction of intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	Bright Light Intervention n = 11
Value	3.3 (2.3)

Bright Light Intervention: p = 0.42, Paired T test, 2-sided

Primary outcome: Insomnia Severity Index Sum Scores

Time frame: two weeks after introduction of intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	Bright Light Intervention n = 11
Value	11.36 (5.89)

Bright Light Intervention: p = 0.65, Paired T test, 2-sided

Primary outcome: Morningness-Eveningness Questionnaire

Time frame: two weeks after introduction of intervention. Count of participants. Unit: Participants

Measure	Bright Light Intervention n = 11
morning types	3
intermediate type	8
evening types	0

Bright Light Intervention: p = 1.0, Fisher Exact

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 29 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bright Light Intervention	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amanda N Leggett, PhD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Re-Timer glasses in people with Depression and Sleep Quality, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (time frame: two weeks after introduction of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02413294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.