Calm + Oura Sleep Study

NCT04514640 | Completed

• 1 other identifier: STUDY00012202
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. 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.
2. 2.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)
3. 3.Objective: Oura ring (sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time, REM/light/deep sleep).
4. 4.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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (5)

• Pittsburgh Sleep Diaries

  Sleep diaries assessing sleep/wake time and sleep quality

  Daily for 6 weeks

• Pre-Sleep Arousal Survey

  Cognitive and somatic pre-sleep arousal

  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

• Fatigue Severity Scale

  Daytime fatigue

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

• Epworth Sleepiness Scale

  Daytime sleepiness

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

• Insomnia Severity Index

  Symptoms of insomnia

  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 (8)

• Heart rate

  Daily for 6 weeks

• Heart rate variability

  Daily for 6 weeks

• Respiratory rate

  Daily for 6 weeks

• Sleep onset

  Daily for 6 weeks

• Sleep efficiency

  Daily for 6 weeks

Study Arms (3)

General Meditation

EXPERIMENTAL

Participants will be asked to meditate every day during the daytime for at least 10 min/session. Participants can use any general meditation including the "Daily Calm" which can be found on the homepage or by clicking on the "meditate" tab in the app. Participants will be asked to not choose any sleep meditations or Sleep Stories.

Behavioral: The Calm app

Sleep Meditation

EXPERIMENTAL

Participants will be asked to meditate every day just before going to bed for at least 10 min/session. Participants can use any sleep meditations which can be found by clicking on the "meditate" tab and then "sleep". Particpiants will be asked to not choose any general meditations including the Daily Calm or Sleep Stories.

Behavioral: The Calm app

Sleep Stories

EXPERIMENTAL

Participants will be asked to listen to a Sleep Story every day just before going to bed for at least 10 min/session. Participants can listen to any Sleep Story which can be found by clicking on the "sleep" tab. Participants will be asked to not choose any general meditations including the Daily Calm or sleep meditations.

Behavioral: The Calm app

Interventions

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.

General Meditation; Sleep Meditation; Sleep Stories

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Oura employees who do not own an Oura ring

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 17, 2020
• Study Start: July 27, 2020
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)