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Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators (REST)

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ClinicalTrials.gov Identifier: NCT05026541
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

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.




Primary Outcome Measures :
  1. Error frequency Change: Go-No Go Task [ Time Frame: 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 :
  1. Reaction Time Change: Go-No Go [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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:

  1. History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis)
  2. History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder)
  3. Current use of cognition enhancing medications
  4. Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week)
  5. History (within the last 5 years) of stroke/aneurysm
  6. Recent history (< 3 months) of seizures
  7. 60 years of age or older
  8. History of Heart Attack and Ejection Fraction less than or equal to 30%
  9. Pregnancy
  10. Non-English speaking
  11. History/Diagnosis of any sleep disorder
  12. Consumption of 3 or more cups of coffee a day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05026541


Contacts
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Contact: Balachundhar Subramaniam, MD, MPH 617-667-2721 sadhgurucenter_research@bidmc.harvard.edu
Contact: Sepideh Hariri, PhD 617-667-2721 sadhgurucenter_research@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Centre Recruiting
Boston, Massachusetts, United States, 02215
Contact: Balachundhar Subramaniam, MD, MPH    617-667-2721    sadhgurucenter_research@bidmc.harvard.edu   
Principal Investigator: Balachundhar Subramaniam, MD, MPH         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Balachundhar Subramaniam, MD, MPH Beth Israel Deaconess Medical Center
Publications:

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Responsible Party: Balachundhar Subramaniam, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05026541    
Other Study ID Numbers: 2021P000544
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Balachundhar Subramaniam, Beth Israel Deaconess Medical Center:
sleep
sleep disorder
sleep deprivation
Meditation
Shoonya meditation
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders