N/A N=12 Prevention

Sleep to Activate Mood Promotion

Depression · Sleep Quality

Bottom Line

View on ClinicalTrials.gov: NCT02413294 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Pittsburgh Sleep Quality Index — 7.0 units on a scale — p=0.37

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Re-Timer glasses (Device)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Pittsburgh Sleep Quality Index	7.0	0.37
PRIMARY Patient Health Questionnaire-9 Depression Scale	3.3	0.42
PRIMARY Insomnia Severity Index Sum Scores	11.36	0.65
PRIMARY Morningness-Eveningness Questionnaire	3; 8; 0	1.0
SECONDARY Actigraph Sleep Data: Minutes Asleep	405.2; 402.2	0.65
SECONDARY Actigraph: Number of Awakenings	22.1; 22.4	0.65
SECONDARY Actigraph: Efficiency	85.0; 85.1	0.94
SECONDARY Fitbit Sleep Data: Sleep Duration	425.4; 428.3	0.81
SECONDARY Fitbit Sleep Data: Night Awakenings	13.4; 15.8	0.40
SECONDARY Fitbit Sleep Data: Sleep Efficiency	91.2; 90.6	0.46
SECONDARY Self-Reported Sleep Diary: Time at Which Participants go to Bed	24; 23.8	<0.01 sig
SECONDARY Self-Reported Sleep Diary: Time at Which Participants Wake up	7.8; 7.5	0.28
SECONDARY Self-Reported Sleep Diary: Sleep Quality	2.3; 2.4	0.67
SECONDARY Self-Reported Sleep Diary: Night Awakenings	2.2; 2.1	0.56
SECONDARY Self-Reported Sleep Diary: Sleep Duration	429.3; 433.3	0.82

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02413294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.