Clinical trial NCT04514640: Calm + Oura Sleep Study
Official title: A Quasi-experimental Study Testing a Mindfulness Meditation Mobile App on Sleep and Neurophysiological Outcomes Using the Oura Ring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 72
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 is a quasi-experimental study with pre-post assessment using a convenience sample of Calm and Oura employees. We will employ two weeks of baseline data collection and administer the intervention for four-weeks. Participants will be randomized to one of three groups (i.e., general meditations, sleep meditations, or Sleep Stories). Self-report assessments will be conducted during baseline periods and during week 1 and week 4 of the intervention. Sleep diaries and objective (i.e., Oura ring and Calm app) usage data will be collected on a continual basis during intervention.

The purpose of this study is to:

1. Test the preliminary effects of using Calm (daytime vs nighttime) for four weeks on sleep outcomes (sleep quality, sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time) using self-report and objective measures.

   1. Self-report: Sleep diaries, pre-sleep arousal (Pre-Sleep Arousal Survey), fatigue (Fatigue Severity Scale), daytime sleepiness (Epworth Sleepiness Scale), insomnia (Insomnia Severity Index), sleep quality (Pittsburgh Sleep Quality Index)
   2. Objective: Oura ring (sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time, REM/light/deep sleep).
2. Test the preliminary effects of using Calm (daytime vs nighttime) on neurophysiological outcomes \[heart rate variability (HRV), heart rate, respiratory rate\] as measured by the Oura ring during meditation and after four-weeks of mobile meditation practice.

Detailed description: More than 30% of the US population reports sleep disturbances, and the Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic. Current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for insomnia, Relaxation Therapy) are lengthy and limited due to the need for specialized providers. Pharmaco-therapy may help, however they have inherent limitations (e.g., tolerance, side effects, interactions) to their use. Novel treatments that effectively and conveniently address sleep disturbances (i.e., help individuals self-manage sleep) need further investigation.

Commercially available mobile applications (apps) may help individuals self-manage health conditions conveniently at low cost and with little to no side effects. Specifically, mindfulness-based interventions (e.g., mindfulness meditation) targeting sleep and delivered via a mobile app may be an attractive, feasible and effective solution to improve sleep. Few, if any sleep interventions testing mobile meditation apps have assessed their effects on sleep and most studies only include self-report measures rather than objective measures of sleep (e.g., portable sleep trackers). Additionally, no studies have assessed the neurophysiological changes (heart rate variability, heart rate, respiratory rate) during or with prolonged use of a mindfulness meditation mobile app and whether these changes vary based on time of day. Thus, there is an unexplored opportunity to efficiently and effectively test the use of a mindfulness meditation mobile app on sleep and neurophysiological outcomes.

Findings from our previous study testing the effects of the mindfulness meditation mobile app called Calm on sleep outcomes (manuscript in review; PloS one), suggest that the Calm app improves self-reported sleep quality, and decreases daytime fatigue, daytime sleepiness, and cognitive/somatic pre-sleep arousal in sleep disturbed adults. However, we did not collect any objective data to confirm these findings and are unsure if these findings can be replicated in otherwise healthy adults. We also did not collect any neurophysiological outcomes during meditation practice.

Therefore, the purpose of this study is to:

1. Test the preliminary effects of using Calm (daytime vs nighttime) for four weeks on sleep outcomes (sleep quality, sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time) using self-report and objective measures.

   1. Self-report: Sleep diaries (Pittsburgh Sleep Diaries), pre-sleep arousal (Pre-Sleep Arousal Survey), fatigue (Fatigue Severity Scale), and daytime sleepiness (Epworth Sleepiness Scale), insomnia (Insomnia Severity Index)
   2. Objective: Oura ring (sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time, REM/light/deep sleep).
2. Test the preliminary effects of using Calm (daytime vs nighttime) on neurophysiological outcomes \[heart rate variability (HRV), heart rate, respiratory rate\] as measured by the Oura ring during meditation and after four-weeks of mobile meditation practice.

The Calm app provides daily, 10-minute, guided general meditations as well as sleep-focused meditations grounded in mindfulness-based stress reduction (MBSR) and Vipassana meditation. Uniquely, Calm also offers "Sleep Stories", developed using techniques from Cognitive Behavioral Therapy and Relaxation Technique.

The Oura Ring is a portable wearable device designed to be worn on the finger. The device includes a 3D accelerometer and gyroscope to measure light, deep, and rapid eye movement sleep. The device also measures heart rate, heart rate variability, and respiratory rate. The Oura Ring has shown promise as a tool to measure sleep outcomes when compared to the gold standard polysomnography.

Study design: This is a quasi-experimental study with pre-post assessment using a convenience sample of Calm and Oura employees. We will employ two weeks of baseline data collection and administer the intervention for four-weeks. Participants will be randomized to one of three groups (i.e., general meditations, sleep meditations, or Sleep Stories). Self-report assessments will be conducted during baseline periods and during week 1 and week 4 of the intervention. Sleep diaries and objective (i.e., Oura ring and Calm app) usage data will be collected on a continual basis during intervention.

Eligibility criteria: Inclusion Criteria:

* Employee of Calm or Oura
* \>18 years of age
* English speaking
* Willing to download the Calm app to their smartphone
* Willing to wear Oura ring
* Willing to be randomized.

Exclusion Criteria:

* Oura employees who do not own an Oura ring

Primary outcomes:
measure: Pittsburgh Sleep Diaries
timeFrame: Daily for 6 weeks
measure: Pre-Sleep Arousal Survey
timeFrame: Change from baseline pre-sleep arousal at 4-weeks; 16-items (8-items measure cognitive arousal and 8-items measure somatic arousal); Scores range from 8-40 with higher scores indicating greater pre-sleep arousal
measure: Fatigue Severity Scale
timeFrame: Change from baseline fatigue at 4-weeks; 9-items; Scores range from 1-7 with higher scores indicating higher levels of fatigue.
measure: Epworth Sleepiness Scale
timeFrame: Change from baseline daytime sleepiness at 4-weeks; 8-items; Scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
measure: Insomnia Severity Index
timeFrame: Change from baseline symptoms of insomnia at 4-weeks; 7-items; Scores range from 0-28 with higher scores indicating greater symptoms of insomnia.
Secondary outcomes:
measure: Heart rate
timeFrame: Daily for 6 weeks
measure: Heart rate variability
timeFrame: Daily for 6 weeks
measure: Respiratory rate
timeFrame: Daily for 6 weeks
measure: Sleep onset
timeFrame: Daily for 6 weeks
measure: Sleep efficiency
timeFrame: Daily for 6 weeks
measure: number of nightime awakenings
timeFrame: Daily for 6 weeks
measure: Total sleep time
timeFrame: Daily for 6 weeks
measure: Sleep stages
timeFrame: Daily for 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: