Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514640
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2020-08-11
Brief Title:
Calm Oura Sleep Study
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
A Quasi-experimental Study Testing a Mindfulness Meditation Mobile App on Sleep and Neurophysiological Outcomes Using the Oura Ring
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie 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 REMlightdeep 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 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 REMlightdeep 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 eg 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 eg tolerance side effects interactions to their use Novel treatments that effectively and conveniently address sleep disturbances ie 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 eg 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 eg 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 cognitivesomatic 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 REMlightdeep 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 ie 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 ie Oura ring and Calm app usage data will be collected on a continual basis during intervention
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 eg 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 eg 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 cognitivesomatic 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 REMlightdeep 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 ie 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 ie Oura ring and Calm app usage data will be collected on a continual basis during intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None