Chorus Sleep Trial

NCT ID: NCT05434143

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2022-10-24

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:

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

Conditions

Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chorus Sleep

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chorus Wellness Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Online

San Francisco, California, United States

Countries

United States

Other Identifiers

CS-0001

Identifier Type: -

Identifier Source: org_study_id