Chorus Sleep Trial

NCT05434143 | Completed

• 1 other identifier: CS-0001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance

Keywords

mindfulness; breathwork; meditation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in perceived stress

  Within 24 hours pre-and within 1 week post- 6 week intervention

• Change in depression symptoms

  Within 24 hours pre-and within 1 week post- 6 week intervention

• Change in anxiety symptoms from baseline to 6-week follow-up.

  Within 24 hours pre-and within 1 week post- 6 week intervention

• Demand, based on frequency of use of the Chorus Sleep app

  Recorded continuously throughout 6-week intervention

Other Outcomes (4)

• Daily self-reported sleep disturbance, as measured by time to fall asleep, on the in-app sleep survey.

  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

  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.

  Recorded daily throughout the 6 week intervention (intervention group only)

Study Arms (2)

Chorus Sleep

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

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.

Interventions

Chorus Sleep BEHAVIORAL

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.

Chorus Sleep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chorus Wellness Inc.: lead

Study Sites (1)

Online

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a waitlist controlled design to a behavioral intervention. Assignment will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 27, 2022
• Study Start: May 16, 2022
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Study protocol and analytic code will be shared publicly upon publication in a journal and/or upload of to a preprint server.
• Access Criteria: Unrestricted

Locations

US (1)