Chorus Sleep Trial

Chorus Sleep Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance
• Intervention / Treatment: Behavioral: Chorus Sleep

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:

1. Pilot a randomized controlled trial on Chorus sleep to evaluate feasibility.
2. Evaluate the effect of Chorus sleep practice at improving sleep quality.
3. Evaluate the effect of Chorus sleep practice at reducing perceived stress, depression, and anxiety, both directly and indirectly through improved sleep quality.
4. Characterize habit formation of Chorus sleep practice

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94103
      • Online

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chorus Sleep; 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.	Behavioral: Chorus Sleep; 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.
No Intervention: Waitlist; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 24 hours pre-and within 1 week post- 6 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 24 hours pre-and within 1 week post- 6 week intervention
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.	Within 24 hours pre-and within 1 week post- 6 week intervention
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.	Within 24 hours pre-and within 1 week post- 6 week intervention
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.	Recorded continuously throughout 6-week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily self-reported sleep disturbance, as measured by time to fall asleep, on the in-app sleep survey.	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.	Recorded daily throughout the 6 week intervention (intervention group only)
Daily self-reported sleep disturbance, as measured by number of awakenings on the in-app sleep survey	Daily reports of number of awakenings on the in-app sleep survey with options from 0-more than 4 times in increments of 1.	Recorded daily throughout the 6 week intervention (intervention group only)
Daily self-reported sleep disturbance, as measured by total time awake on the in-app sleep survey.	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	Recorded daily throughout the 6 week intervention (intervention group only)
Habit formation	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.	within 1 week post- 6 week intervention

Collaborators and Investigators

• Sponsor: Chorus Wellness Inc.

Publications and helpful links

Helpful Links

• Interested potential participants can find information about how to sign up for the trial here.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): October 24, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: mindfulness; meditation; breathwork
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: CS-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No