Clinical trial NCT05026541: Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators
Official title: Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Sleep Deprivation
Cognitive Change
Keywords: sleep
sleep disorder
sleep deprivation
Meditation
Shoonya meditation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Sleep is physiologically important for memory consolidation, mood and hormonal regulation, and maintaining low levels of systemic inflammation. However, a substantial proportion of 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 prospective cohort study where subjects are asked to learn and practice a 15-minute meditation (shoonya meditation) or continue their usual routine. 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.

The intervention group will be asked to undergo these same study procedures after 2 months of meditation practice. The control group, which continues their usual routine, will only undergo one visit.

Eligibility 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
13. Previously learned shoonya meditation (for the meditator groups)

Primary outcomes:
measure: Error frequency Change: Go-No Go Task
timeFrame: 2 months post learning meditation
Secondary outcomes:
measure: Reaction Time Change: Go-No Go
timeFrame: 2 months post learning meditation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundhar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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