REST: Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05026541

Collaborator

(none)

Enrollment

Location

Arms

15.5

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the effect of a 15-minute meditation practice on sleep architecture and high-frequency Heart Rate Variability (HF-HRV), as well as cognitive performance after both a well-rested and sleep-deprived night.

Condition or Disease	Intervention/Treatment	Phase
Sleep Sleep Deprivation Cognitive Change	Behavioral: Nap Practitioners Behavioral: Shoonya Meditation Behavioral: Shukha Kriya Practice	N/A

Detailed Description

Sleep is physiologically important for memory consolidation, mood and hormonal regulation, and maintaining low levels of systemic inflammation. However, a substantial proportion oy f people are reported to regularly sleep less than the recommended 7-9 hours a night. Meditation may be a means to mitigate the negative effects of sleep deprivation, as many types of meditations are associated with increasing high-frequency heart rate variability (HF-HRV), which is an index of parasympathetic control of the heart. Greater parasympathetic drive may be associated with physiological buffering of the detrimental effects of sleep deprivation.

The investigators want to conduct a waitlisted randomized control trial where subjects are asked to learn and practice a 15-minute meditation (shoonya meditation) or 15 minutes of alternate nostril breathing, twice a day. Subjects will be asked to complete some cognitive tests before and after a night of sleep and a night of sleep deprivation. During the night of sleep, participants will undergo polysomnography recording for sleep architecture and quality.

Subjects will be asked to undergo these same study procedures after 2 months of meditation practice, after which the alternate nostril breathing group will also learn shoonya meditation. Only this group will asked to undergo the same study procedures for a third time, after they have practiced shoonya meditation for 2 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Nap Practitioners This is an observational arm of regular nappers. Individuals that take naps at least three times a week will be invited to undergo all of the study procedures for one weekend of data collection.	Behavioral: Nap Practitioners Regular nappers will be given a 30 minute nap opportunity to nap for as long as they please.
Active Comparator: Shoonya Meditators This is intervention arm. Participants will learn and practice the fifteen minute shoonya meditation - described as a process of conscious non-doing- and shakti chalana kriya, which is a set of breathing exercises designed as a preparatory practice to shoonya meditation. Participants will practice shoonya meditation twice a day for two months. A weekend of data collection will happen at baseline and two months after they learn the practice.	Behavioral: Shoonya Meditation This is a 15 minute meditation, described as a process of conscious non-doing.
Placebo Comparator: Control Meditators This is the waitlisted control arm. Participants will practice alternate nostril breathing (sukha kriya) for two months, then will learn shoonya meditation and practice for two months. A weekend of data collection will happen at baseline, two months, and four months.	Behavioral: Shoonya Meditation This is a 15 minute meditation, described as a process of conscious non-doing. Behavioral: Shukha Kriya Practice This is a practice of alternate nostril breathing, in which one nostril is closed by the right hand while breathing occurs slowly through the other. The open nostril is alternated after every inhalation.

Arm

Intervention/Treatment

Sham Comparator: Nap Practitioners

This is an observational arm of regular nappers. Individuals that take naps at least three times a week will be invited to undergo all of the study procedures for one weekend of data collection.

Behavioral: Nap Practitioners

Regular nappers will be given a 30 minute nap opportunity to nap for as long as they please.

Active Comparator: Shoonya Meditators

This is intervention arm. Participants will learn and practice the fifteen minute shoonya meditation - described as a process of conscious non-doing- and shakti chalana kriya, which is a set of breathing exercises designed as a preparatory practice to shoonya meditation. Participants will practice shoonya meditation twice a day for two months. A weekend of data collection will happen at baseline and two months after they learn the practice.

Behavioral: Shoonya Meditation

This is a 15 minute meditation, described as a process of conscious non-doing.

Placebo Comparator: Control Meditators

This is the waitlisted control arm. Participants will practice alternate nostril breathing (sukha kriya) for two months, then will learn shoonya meditation and practice for two months. A weekend of data collection will happen at baseline, two months, and four months.

Behavioral: Shoonya Meditation

This is a 15 minute meditation, described as a process of conscious non-doing.

Behavioral: Shukha Kriya Practice

This is a practice of alternate nostril breathing, in which one nostril is closed by the right hand while breathing occurs slowly through the other. The open nostril is alternated after every inhalation.

Outcome Measures

Primary Outcome Measures

Error frequency Change: Go-No Go Task [2 months post learning meditation]
The primary outcome is the difference in number of commission and omission errors on the Go-No Go task. The difference in scores pre- and post-sleep deprivation will be analyzed between the control and intervention group.

Secondary Outcome Measures

Reaction Time Change: Go-No Go [2 months post learning meditation]
The difference in reaction times on the Go-No Go task. The difference in scores pre- and post-sleep deprivation will compared between the control and intervention groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Shoonya meditation program participants/individuals eligible to participate who are healthy adults of age 18 or older, and reside in the United States. Participants must be able and willing to travel to Boston.
Nap Group: Healthy adults of age 18 or older that reside in the United States, nap regularly (at least 3 times a week), and do not meditate regularly.

Exclusion Criteria:

History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis)
History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder)
Current use of cognition enhancing medications
Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week)
History (within the last 5 years) of stroke/aneurysm
Recent history (< 3 months) of seizures
60 years of age or older
History of Heart Attack and Ejection Fraction less than or equal to 30%
Pregnancy
Non-English speaking
History/Diagnosis of any sleep disorder
Consumption of 3 or more cups of coffee a day
Previously learned shoonya meditation (for the meditator groups)