Clinical trial NCT05434143: Chorus Sleep Trial
Official title: Chorus Sleep Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Keywords: mindfulness
breathwork
meditation
Lead sponsor: Chorus Wellness Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
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
timeFrame: Within 24 hours pre-and within 1 week post- 6 week intervention
Secondary outcomes:
measure: Change in perceived stress
timeFrame: Within 24 hours pre-and within 1 week post- 6 week intervention
measure: Change in depression symptoms
timeFrame: Within 24 hours pre-and within 1 week post- 6 week intervention
measure: Change in anxiety symptoms from baseline to 6-week follow-up.
timeFrame: Within 24 hours pre-and within 1 week post- 6 week intervention
measure: Demand, based on frequency of use of the Chorus Sleep app
timeFrame: Recorded continuously throughout 6-week intervention
Other outcomes:
measure: Daily self-reported sleep disturbance, as measured by time to fall asleep, on the in-app sleep survey.
timeFrame: Recorded daily throughout the 6 week intervention (intervention group only)
measure: Daily self-reported sleep disturbance, as measured by number of awakenings on the in-app sleep survey
timeFrame: Recorded daily throughout the 6 week intervention (intervention group only)
measure: Daily self-reported sleep disturbance, as measured by total time awake on the in-app sleep survey.
timeFrame: Recorded daily throughout the 6 week intervention (intervention group only)
measure: Habit formation
timeFrame: within 1 week post- 6 week intervention
Locations:
city: San Francisco
country: United States
facility: Online
state: California
Study officials:
References: