Skip to main content
OpenTrials
Completed

NCT Number: NCT04514640

Calm + Oura Sleep Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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:

  • 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.
  • 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)
  • Objective: Oura ring (sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time, REM/light/deep sleep).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Calm App

Behavioral

All participants (n=100) will be asked to download the Calm app to their phone. Participants will then receive an email containing 4-weeks of free access to Calm. All participants be asked to use Calm once per day for at least 10 minutes based on their group assignment (i.e., general meditation during daytime, sleep meditation before bed, or sleep stories before bed). Participants will be asked to turn on the "take a moment" feature in the Oura app in order for the Oura ring to collect neurophysiological measures before, during, and after meditations. Additionally, participants will be asked to complete sleep diaries every day throughout the intervention.

Primary outcomes

  1. Pittsburgh Sleep Diaries

    Time frame: Daily for 6 weeks

    Sleep diaries assessing sleep/wake time and sleep quality

  2. Pre-Sleep Arousal Survey

    Time frame: 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

    Cognitive and somatic pre-sleep arousal

  3. Fatigue Severity Scale

    Time frame: Change from baseline fatigue at 4-weeks; 9-items; Scores range from 1-7 with higher scores indicating higher levels of fatigue.

    Daytime fatigue

  4. Epworth Sleepiness Scale

    Time frame: Change from baseline daytime sleepiness at 4-weeks; 8-items; Scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness.

    Daytime sleepiness

  5. Insomnia Severity Index

    Time frame: Change from baseline symptoms of insomnia at 4-weeks; 7-items; Scores range from 0-28 with higher scores indicating greater symptoms of insomnia.

    Symptoms of insomnia

Secondary outcomes

  1. Heart rate

    Time frame: Daily for 6 weeks

    beats per minute collected from Oura ring

  2. Heart rate variability

    Time frame: Daily for 6 weeks

    interbeat interval collected from Oura ring

  3. Respiratory rate

    Time frame: Daily for 6 weeks

    Number of breaths per minute collected from Oura ring

  4. Sleep onset

    Time frame: Daily for 6 weeks

    Time went to bed collected from Oura ring

  5. Sleep efficiency

    Time frame: Daily for 6 weeks

    Percent of time in bed compared to total sleep time collected from Oura ring

  6. number of nightime awakenings

    Time frame: Daily for 6 weeks

    Number of times spent awake during the night collected from Oura ring

  7. Total sleep time

    Time frame: Daily for 6 weeks

    Number of minutes slept at night collected from Oura ring

  8. Sleep stages

    Time frame: Daily for 6 weeks

    minutes of sleep spent in rapid eye movement, light, or deep collected from Oura ring

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

A Quasi-experimental Study Testing a Mindfulness Meditation Mobile App on Sleep and Neurophysiological Outcomes Using the Oura Ring

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2020
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.