Trial Outcomes & Findings for Sleep to Activate Mood Promotion (NCT NCT02413294)

NCT ID: NCT02413294

Last Updated: 2017-04-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: two weeks after introduction of intervention
• Results posted on: 2017-04-07

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

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.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Sleep to Activate Mood Promotion

Baseline characteristics by cohort

Measure	Bright Light Intervention n=11 Participants 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.
Age, Continuous	66.6 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian American	1 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants
Patient Health Questionnaire-9 Baseline	5.6 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants
Patient Health Questionnaire-9 After 2 wks sleep tracking/prior to intervention	3.7 units on a scale STANDARD_DEVIATION 3.2 • n=5 Participants
Pittsburgh Sleep Quality Index Baseline	8.3 units on a scale STANDARD_DEVIATION 4.1 • n=5 Participants
Pittsburgh Sleep Quality Index After 2 wks sleep tracking/prior to intervention	7.6 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants
Insomnia Severity Index Initial baseline measurement	13.09 units on a scale STANDARD_DEVIATION 4.85 • n=5 Participants
Insomnia Severity Index After 2 wks sleep tracking/prior to intervention 3	11.86 units on a scale STANDARD_DEVIATION 5.51 • n=5 Participants
Morningness/Eveningness Questionnaire Morning type	2 Participants n=5 Participants
Morningness/Eveningness Questionnaire Intermediate type	8 Participants n=5 Participants
Morningness/Eveningness Questionnaire Evening type	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Bright Light Intervention n=11 Participants 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.

Pittsburgh Sleep Quality Index

7.0 units on a scale Standard Deviation 3.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Bright Light Intervention n=11 Participants 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.

Patient Health Questionnaire-9 Depression Scale

3.3 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Bright Light Intervention n=11 Participants 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.

Insomnia Severity Index Sum Scores

11.36 units on a scale Standard Deviation 5.89

PRIMARY outcome

Timeframe: two weeks after introduction of intervention

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

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Morningness-Eveningness Questionnaire morning types	3 Participants
Morningness-Eveningness Questionnaire intermediate type	8 Participants
Morningness-Eveningness Questionnaire evening types	0 Participants

SECONDARY outcome

Timeframe: daily for 4 weeks- baseline and intervention period

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

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Actigraph Sleep Data: Minutes Asleep 2 weeks monitoring prior to ReTimer use	405.2 minutes Standard Deviation 27.9
Actigraph Sleep Data: Minutes Asleep 2 weeks with ReTimer Glasses	402.2 minutes Standard Deviation 24.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Actigraph: Number of Awakenings 2 weeks monitoring prior to ReTimer use	22.1 count of awakenings Standard Deviation 6.2
Actigraph: Number of Awakenings 2 weeks with ReTimer Glasses	22.4 count of awakenings Standard Deviation 5.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Actigraph: Efficiency 2 weeks monitoring prior to ReTimer use	85.0 percentage of time in bed spent asleep Standard Deviation 4.5
Actigraph: Efficiency 2 weeks with ReTimer Glasses	85.1 percentage of time in bed spent asleep Standard Deviation 4.0

SECONDARY outcome

Timeframe: daily for 4 weeks- baseline and intervention period

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

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Fitbit Sleep Data: Sleep Duration 2 weeks monitoring prior to ReTimer use	425.4 Minutes asleep Standard Deviation 33.6
Fitbit Sleep Data: Sleep Duration 2 weeks with ReTimer Glasses	428.3 Minutes asleep Standard Deviation 36.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Fitbit Sleep Data: Night Awakenings 2 weeks monitoring prior to ReTimer use	13.4 count of night awakenings Standard Deviation 3.9
Fitbit Sleep Data: Night Awakenings 2 weeks with ReTimer Glasses	15.8 count of night awakenings Standard Deviation 11.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Fitbit Sleep Data: Sleep Efficiency 2 weeks monitoring prior to ReTimer use	91.2 percentage of time in bed spent asleep Standard Deviation 2.2
Fitbit Sleep Data: Sleep Efficiency 2 weeks with ReTimer Glasses	90.6 percentage of time in bed spent asleep Standard Deviation 4.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Self-Reported Sleep Diary: Time at Which Participants go to Bed 2 weeks monitoring prior to ReTimer use	24 hour (military time) Standard Deviation 1.4
Self-Reported Sleep Diary: Time at Which Participants go to Bed 2 weeks with ReTimer Glasses	23.8 hour (military time) Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Self-Reported Sleep Diary: Time at Which Participants Wake up 2 weeks monitoring prior to ReTimer us	7.8 hour (military time) Standard Deviation 1.8
Self-Reported Sleep Diary: Time at Which Participants Wake up 2 weeks of ReTimer use	7.5 hour (military time) Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Self-Reported Sleep Diary: Sleep Quality 2 weeks monitoring prior to ReTimer use	2.3 units on a scale Standard Deviation 0.5
Self-Reported Sleep Diary: Sleep Quality 2 weeks with ReTimer Glasses	2.4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Self-Reported Sleep Diary: Night Awakenings 2 weeks monitoring prior to ReTimer use	2.2 Number of night awakenings Standard Deviation 1.3
Self-Reported Sleep Diary: Night Awakenings 2 weeks with ReTimer Glasses	2.1 Number of night awakenings Standard Deviation 1.0

SECONDARY outcome

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

nightly mean of length of sleep measured in minutes

Outcome measures

Measure	Bright Light Intervention n=11 Participants 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.
Self-Reported Sleep Diary: Sleep Duration 2 weeks monitoring prior to ReTimer use	429.3 Minutes asleep Standard Deviation 28.2
Self-Reported Sleep Diary: Sleep Duration 2 weeks with ReTimer Glasses	433.3 Minutes asleep Standard Deviation 56.5

Adverse Events

Bright Light Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amanda Leggett

University of Michigan

Phone: 734-232-0538

Email: leggetta@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place