Sleep to Activate Mood Promotion

Sleep to Activate Mood Promotion- Intervention

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02413294

Acronym

STAMP

Enrollment

Registered

2015-04-09

Start date

2015-04-30

Completion date

2016-03-31

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Sleep Quality

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.

Interventions

DEVICERe-Timer glasses

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pittsburgh Sleep Quality Index	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	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	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	two weeks after introduction of intervention	The morningness- eveningness categories represent the time of day when a person is at their peak alertness.

Secondary

Measure	Time frame	Description
Fitbit Sleep Data: Night Awakenings	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.
Fitbit Sleep Data: Sleep Efficiency	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).
Self-Reported Sleep Diary: Time at Which Participants go to Bed	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.
Actigraph Sleep Data: Minutes Asleep	daily for 4 weeks- baseline and intervention period	mean nightly sleep duration for each of the two-week periods: baseline and intervention
Self-Reported Sleep Diary: Sleep Quality	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).
Self-Reported Sleep Diary: Night Awakenings	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
Self-Reported Sleep Diary: Sleep Duration	daily for 4 weeks- baseline and intervention period to be compared	nightly mean of length of sleep measured in minutes
Self-Reported Sleep Diary: Time at Which Participants Wake up	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.
Actigraph: Number of Awakenings	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.
Actigraph: Efficiency	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.
Fitbit Sleep Data: Sleep Duration	daily for 4 weeks- baseline and intervention period	mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention

Countries

United States

Participant flow

Participants by arm

Arm	Count
Bright Light Intervention 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. Re-Timer glasses: 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.	11
Total	11

Arm

Count

Bright Light Intervention

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. Re-Timer glasses: 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Bright Light Intervention
Age, Continuous	66.6 years STANDARD_DEVIATION 1.5
Insomnia Severity Index After 2 wks sleep tracking/prior to intervention 3	11.86 units on a scale STANDARD_DEVIATION 5.51
Insomnia Severity Index Initial baseline measurement	13.09 units on a scale STANDARD_DEVIATION 4.85
Morningness/Eveningness Questionnaire Evening type	1 Participants
Morningness/Eveningness Questionnaire Intermediate type	8 Participants
Morningness/Eveningness Questionnaire Morning type	2 Participants
Patient Health Questionnaire-9 After 2 wks sleep tracking/prior to intervention	3.7 units on a scale STANDARD_DEVIATION 3.2
Patient Health Questionnaire-9 Baseline	5.6 units on a scale STANDARD_DEVIATION 3.9
Pittsburgh Sleep Quality Index After 2 wks sleep tracking/prior to intervention	7.6 units on a scale STANDARD_DEVIATION 3.7
Pittsburgh Sleep Quality Index Baseline	8.3 units on a scale STANDARD_DEVIATION 4.1
Race/Ethnicity, Customized Asian American	1 Participants
Race/Ethnicity, Customized Caucasian	10 Participants
Region of Enrollment United States	11 Participants
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 12
serious Total, serious adverse events	0 / 12

Outcome results

Primary

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.

Time frame: two weeks after introduction of intervention

Arm	Measure	Value (MEAN)	Dispersion
Bright Light Intervention	Insomnia Severity Index Sum Scores	11.36 units on a scale	Standard Deviation 5.89

Comparison: The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.p-value: 0.65Paired T test, 2-sided

Primary

Morningness-Eveningness Questionnaire

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

Time frame: two weeks after introduction of intervention

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Bright Light Intervention	Morningness-Eveningness Questionnaire	morning types	3 Participants
Bright Light Intervention	Morningness-Eveningness Questionnaire	intermediate type	8 Participants
Bright Light Intervention	Morningness-Eveningness Questionnaire	evening types	0 Participants

Primary

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.

Time frame: two weeks after introduction of intervention

Arm	Measure	Value (MEAN)	Dispersion
Bright Light Intervention	Patient Health Questionnaire-9 Depression Scale	3.3 units on a scale	Standard Deviation 2.3

Primary

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.

Time frame: two weeks after introduction of intervention

Arm	Measure	Value (MEAN)	Dispersion
Bright Light Intervention	Pittsburgh Sleep Quality Index	7.0 units on a scale	Standard Deviation 3.4

Secondary

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.