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Chorus Sleep Trial

Primary Purpose

Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chorus Sleep
Sponsored by
Chorus Wellness Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring mindfulness, breathwork, meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fluent English speakers
  • Have an Apple Iphone 8 or later
  • Have a bed to sleep in consistently every night

Exclusion Criteria:

  • Narcolepsy
  • night shift or shift work for more than 2 nights per week.
  • Used the Chorus sleep app more than one time prior to the beginning of the trial.

Sites / Locations

  • Online

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chorus Sleep

Waitlist

Arm Description

During the 6-week intervention, participants will receive daily reminders to complete their daily sleep log and a link to a chorus sleep class for them to listen to that night. The daily sleep class involve listening to 15 minute audio sessions, which include guided mediation and breathing exercises. Participants will be encouraged to complete classes every day but will be asked to complete classes at least 3 times per week in order to be considered as adhering to the intervention. Participation will be tracked based on participants self-reports in the daily sleep logs. Participants who did not adhere to the intervention will be excluded from per-protocol analyses. Participants will complete surveys online at baseline, after 3 weeks, and after 6 weeks. The baseline questionnaires will include demographic information.

Participants will be placed on a 6 week waitlist to access the chorus sleep app. There will be no daily activities for them to complete during those 6 weeks. Participants will complete surveys online at baseline, after 3 weeks, and after 6 weeks. The baseline questionnaires will include demographic information.

Outcomes

Primary Outcome Measures

Preliminary effects of the Chorus Sleep app on sleep related impairment, as assessed by changes in participants' self-reported sleep related impairment from pre- to post- 6-week intervention period
Change in total score on the PROMIS Sleep Related Impairment Scale from baseline to 6-week follow-up. Mean scores across the 8 items will be used. Items are a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where a lower negative score corresponds with greater decreases in sleep disturbance, a higher score corresponds with greater increases in sleep disturbance, and 0 indicates no change.

Secondary Outcome Measures

Change in perceived stress
Change in perceived stress on the Perceived Stress Scale-10 from baseline to 6-week follow-up. Mean scores across the 10 items will be used. Items are on a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where lower negative scores correspond with greater decreases in perceived stress, higher positive scores correspond with greater increases in perceived stress, and 0 indicates no change.
Change in depression symptoms
Change in depression symptoms on the PROMIS® Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a from baseline to 6-week follow-up. Mean scores across the 8 items will be used. Items are on a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where lower negative scores correspond with greater decreases in depression, higher positive scores correspond with greater increases in depression, and 0 indicates no change.
Change in anxiety symptoms from baseline to 6-week follow-up.
Change in anxiety symptoms on the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a from baseline to 6-week follow-up. Mean scores across the 8 items will be used. Items are on a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where lower negative scores correspond with greater decreases in anxiety, higher positive scores correspond with greater increases in anxiety, and 0 indicates no change.
Demand, based on frequency of use of the Chorus Sleep app
The percentage of days in which participants use the chorus sleep app over the course of the 6 week study period.

Full Information

First Posted
May 11, 2022
Last Updated
October 28, 2022
Sponsor
Chorus Wellness Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05434143
Brief Title
Chorus Sleep Trial
Official Title
Chorus Sleep Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chorus Wellness Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study will evaluate the feasibility of a 6-week intervention using Chorus Sleep's ios app to improve sleep quality, reduce stress, and reduce depression and anxiety using a randomized controlled design.
Detailed Description
Chorus Sleep is a successful wellness company with a loyal and growing clientele, and considerable qualitative and anecdotal evidence for its efficacy at reducing stress, and improving sleep quality. It builds upon existing meditation and mindfulness practices with well documented efficacy for reducing pain, improving mental health, and reducing stress. Further its innovative approach - including the use of popular music and breathwork patterns that elicit stimulating and novel sensations and physiological activity - may removes barriers to participation and engagement of many traditional meditation and mindfulness practices. Prior research evaluating the efficacy of audio meditation using the Calm app found use of the app for eight weeks significantly decreased daytime fatigue and sleepiness and pre-sleep arousal compared to a wait-list control group. Further, use of the calm app for 8 weeks was associated with greater improvements in depression and anxiety symptoms, and those effects were mediated by lower pre-sleep arousal. This study will investigate whether Chorus Sleep's innovation in auditory app-based sleep inventions will demonstrate similar efficacy. This study has the following objectives: Pilot a randomized controlled trial on Chorus sleep to evaluate feasibility. Evaluate the effect of Chorus sleep practice at improving sleep quality. Evaluate the effect of Chorus sleep practice at reducing perceived stress, depression, and anxiety, both directly and indirectly through improved sleep quality. Characterize habit formation of Chorus sleep practice

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
mindfulness, breathwork, meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
This is a waitlist controlled design to a behavioral intervention. Assignment will not be masked.
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chorus Sleep
Arm Type
Experimental
Arm Description
During the 6-week intervention, participants will receive daily reminders to complete their daily sleep log and a link to a chorus sleep class for them to listen to that night. The daily sleep class involve listening to 15 minute audio sessions, which include guided mediation and breathing exercises. Participants will be encouraged to complete classes every day but will be asked to complete classes at least 3 times per week in order to be considered as adhering to the intervention. Participation will be tracked based on participants self-reports in the daily sleep logs. Participants who did not adhere to the intervention will be excluded from per-protocol analyses. Participants will complete surveys online at baseline, after 3 weeks, and after 6 weeks. The baseline questionnaires will include demographic information.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants will be placed on a 6 week waitlist to access the chorus sleep app. There will be no daily activities for them to complete during those 6 weeks. Participants will complete surveys online at baseline, after 3 weeks, and after 6 weeks. The baseline questionnaires will include demographic information.
Intervention Type
Behavioral
Intervention Name(s)
Chorus Sleep
Intervention Description
During the 6-week intervention, participants will receive daily reminders to complete their daily sleep log and a link to a chorus sleep class for them to listen to that night. The daily sleep class involve listening to 15 minute audio sessions, which include guided mediation and breathing exercises.
Primary Outcome Measure Information:
Title
Preliminary effects of the Chorus Sleep app on sleep related impairment, as assessed by changes in participants' self-reported sleep related impairment from pre- to post- 6-week intervention period
Description
Change in total score on the PROMIS Sleep Related Impairment Scale from baseline to 6-week follow-up. Mean scores across the 8 items will be used. Items are a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where a lower negative score corresponds with greater decreases in sleep disturbance, a higher score corresponds with greater increases in sleep disturbance, and 0 indicates no change.
Time Frame
Within 24 hours pre-and within 1 week post- 6 week intervention
Secondary Outcome Measure Information:
Title
Change in perceived stress
Description
Change in perceived stress on the Perceived Stress Scale-10 from baseline to 6-week follow-up. Mean scores across the 10 items will be used. Items are on a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where lower negative scores correspond with greater decreases in perceived stress, higher positive scores correspond with greater increases in perceived stress, and 0 indicates no change.
Time Frame
Within 24 hours pre-and within 1 week post- 6 week intervention
Title
Change in depression symptoms
Description
Change in depression symptoms on the PROMIS® Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a from baseline to 6-week follow-up. Mean scores across the 8 items will be used. Items are on a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where lower negative scores correspond with greater decreases in depression, higher positive scores correspond with greater increases in depression, and 0 indicates no change.
Time Frame
Within 24 hours pre-and within 1 week post- 6 week intervention
Title
Change in anxiety symptoms from baseline to 6-week follow-up.
Description
Change in anxiety symptoms on the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a from baseline to 6-week follow-up. Mean scores across the 8 items will be used. Items are on a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where lower negative scores correspond with greater decreases in anxiety, higher positive scores correspond with greater increases in anxiety, and 0 indicates no change.
Time Frame
Within 24 hours pre-and within 1 week post- 6 week intervention
Title
Demand, based on frequency of use of the Chorus Sleep app
Description
The percentage of days in which participants use the chorus sleep app over the course of the 6 week study period.
Time Frame
Recorded continuously throughout 6-week intervention
Other Pre-specified Outcome Measures:
Title
Daily self-reported sleep disturbance, as measured by time to fall asleep, on the in-app sleep survey.
Description
Daily reports of time to fall asleep reported on the in-app daily sleep survey with options: Fell asleep within 15 minutes, Fell asleep within 16-30 minutes, Fell asleep within 31-60 minutes, Fell asleep after 60 minutes.
Time Frame
Recorded daily throughout the 6 week intervention (intervention group only)
Title
Daily self-reported sleep disturbance, as measured by number of awakenings on the in-app sleep survey
Description
Daily reports of number of awakenings on the in-app sleep survey with options from 0-more than 4 times in increments of 1.
Time Frame
Recorded daily throughout the 6 week intervention (intervention group only)
Title
Daily self-reported sleep disturbance, as measured by total time awake on the in-app sleep survey.
Description
Daily reports of number of awakenings on the in-app sleep survey with the following options: 0-30 minutes, 31-60 minutes, 1-2 hours, 2 or more hours
Time Frame
Recorded daily throughout the 6 week intervention (intervention group only)
Title
Habit formation
Description
Habit formation for using the Chorus Sleep App will be measured using an adaptation of the Self-Report Behavioral Automaticity Index. Mean scores will be used across 4 items. Possible scores range from 1-5, where higher scores indicate greater automaticity.
Time Frame
within 1 week post- 6 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fluent English speakers Have an Apple Iphone 8 or later Have a bed to sleep in consistently every night Exclusion Criteria: Narcolepsy night shift or shift work for more than 2 nights per week. Used the Chorus sleep app more than one time prior to the beginning of the trial.
Facility Information:
Facility Name
Online
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be made public in an online repository upon publication of results.
IPD Sharing Time Frame
Study protocol and analytic code will be shared publicly upon publication in a journal and/or upload of to a preprint server.
IPD Sharing Access Criteria
Unrestricted
Links:
URL
https://www.chorussleep.com/clinicaltrial/
Description
Interested potential participants can find information about how to sign up for the trial here.

Learn more about this trial

Chorus Sleep Trial

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