Clinical trial NCT02413294: Sleep to Activate Mood Promotion
Official title: Sleep to Activate Mood Promotion- Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Sleep Quality
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: two weeks after introduction of intervention
measure: Patient Health Questionnaire-9 Depression Scale
timeFrame: two weeks after introduction of intervention
measure: Insomnia Severity Index Sum Scores
timeFrame: two weeks after introduction of intervention
measure: Morningness-Eveningness Questionnaire
timeFrame: two weeks after introduction of intervention
Secondary outcomes:
measure: Actigraph Sleep Data: Minutes Asleep
timeFrame: daily for 4 weeks- baseline and intervention period
measure: Actigraph: Number of Awakenings
timeFrame: daily for 4 weeks- baseline and intervention period
measure: Actigraph: Efficiency
timeFrame: daily for 4 weeks- baseline and intervention period
measure: Fitbit Sleep Data: Sleep Duration
timeFrame: daily for 4 weeks- baseline and intervention period
measure: Fitbit Sleep Data: Night Awakenings
timeFrame: daily for 4 weeks- baseline and intervention period
measure: Fitbit Sleep Data: Sleep Efficiency
timeFrame: daily for 4 weeks- baseline and intervention period
measure: Self-Reported Sleep Diary: Time at Which Participants go to Bed
timeFrame: daily for 4 weeks- baseline and intervention period to be compared
measure: Self-Reported Sleep Diary: Time at Which Participants Wake up
timeFrame: daily for 4 weeks- baseline and intervention period to be compared
measure: Self-Reported Sleep Diary: Sleep Quality
timeFrame: daily for 4 weeks- baseline and intervention period to be compared
measure: Self-Reported Sleep Diary: Night Awakenings
timeFrame: daily for 4 weeks- baseline and intervention period to be compared
measure: Self-Reported Sleep Diary: Sleep Duration
timeFrame: daily for 4 weeks- baseline and intervention period to be compared
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amanda N Leggett, PhD
role: PRINCIPAL_INVESTIGATOR
References: