Sleep DisturbanceNCT05434143
Chorus Sleep Trial
A study testing Chorus Sleep in people with Sleep Disturbance, run by Chorus Wellness Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Chorus Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent English speakers
- Have an Apple Iphone 8 or later
- Have a bed to sleep in consistently every night
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Sleep Disturbance
- Being tested
- Chorus Sleep
- Keywords
- mindfulness, breathwork, meditation
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chorus SleepBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours pre-and within 1 week post- 6 week intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Recorded continuously throughout 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start16 May 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chorus Wellness Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434143
- Sponsor's protocol ID
- CS-0001
- Status last verified
- Oct 2022
- First submitted
- 11 May 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made public in an online repository upon publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chorus Sleep Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05434143
- Acronym / sponsor ID
- CS-0001
- Conditions
- Sleep Disturbance
- Keywords
- mindfulness, breathwork, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Chorus Wellness Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chorus Sleep | Experimental | Behavioral: Chorus SleepDuring 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluent English speakers
- Have an Apple Iphone 8 or later
- Have a bed to sleep in consistently every night
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chorus SleepDuring 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. | Behavioural | Chorus Sleep |
Primary outcome
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
Time frame: Within 24 hours pre-and within 1 week post- 6 week intervention
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.
4 secondary outcomes
Change in perceived stress
Time frame: Within 24 hours pre-and within 1 week post- 6 week intervention
Change in depression symptoms
Time frame: Within 24 hours pre-and within 1 week post- 6 week intervention
Change in anxiety symptoms from baseline to 6-week follow-up.
Time frame: Within 24 hours pre-and within 1 week post- 6 week intervention
Demand, based on frequency of use of the Chorus Sleep app
Time frame: Recorded continuously throughout 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Interested potential participants can find information about how to sign up for the trial here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data will be made public in an online repository upon publication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chorus Sleep in people with Sleep Disturbance, run by Chorus Wellness Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Within 24 hours pre-and within 1 week post- 6 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.