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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours pre-and within 1 week post- 6 week intervention
Awards & highlights
Study 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.
Eligible Conditions
- Sleep Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours pre-and within 1 week post- 6 week intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours pre-and within 1 week post- 6 week intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Secondary outcome measures
Change in anxiety symptoms from baseline to 6-week follow-up.
Change in depression symptoms
Change in perceived stress
+1 moreOther outcome measures
Daily self-reported sleep disturbance, as measured by number of awakenings on the in-app sleep survey
Daily self-reported sleep disturbance, as measured by time to fall asleep, on the in-app sleep survey.
Daily self-reported sleep disturbance, as measured by total time awake on the in-app sleep survey.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Chorus SleepExperimental Treatment1 Intervention
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 II: WaitlistActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chorus Sleep
2022
N/A
~150
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Who is running the clinical trial?
Chorus Wellness Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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