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

Sleep Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026541
• Other study ID #: 2021P000544
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Balachundhar Subramaniam, MD, MPH
• Phone: 617-667-2721
• Email: sadhgurucenter_research[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Change
• Sleep
• Sleep Deprivation

Intervention

Behavioral:
• Nap Practitioners
Regular nappers will be given a 30 minute nap opportunity to nap for as long as they please.
• Shoonya Meditation
This is a 15 minute meditation, described as a process of conscious non-doing.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Centre	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (14)

Ben Simon E, Rossi A, Harvey AG, Walker MP. Overanxious and underslept. Nat Hum Behav. 2020 Jan;4(1):100-110. doi: 10.1038/s41562-019-0754-8. Epub 2019 Nov 4. Erratum In: Nat Hum Behav. 2020 Dec;4(12):1321. — View Citation

Braboszcz C, Cahn BR, Levy J, Fernandez M, Delorme A. Increased Gamma Brainwave Amplitude Compared to Control in Three Different Meditation Traditions. PLoS One. 2017 Jan 24;12(1):e0170647. doi: 10.1371/journal.pone.0170647. eCollection 2017. — View Citation

Heyde I, Kiehn JT, Oster H. Mutual influence of sleep and circadian clocks on physiology and cognition. Free Radic Biol Med. 2018 May 1;119:8-16. doi: 10.1016/j.freeradbiomed.2017.11.003. Epub 2017 Nov 10. — View Citation

Hirshkowitz M, Whiton K, Albert SM, Alessi C, Bruni O, DonCarlos L, Hazen N, Herman J, Katz ES, Kheirandish-Gozal L, Neubauer DN, O'Donnell AE, Ohayon M, Peever J, Rawding R, Sachdeva RC, Setters B, Vitiello MV, Ware JC, Adams Hillard PJ. National Sleep Foundation's sleep time duration recommendations: methodology and results summary. Sleep Health. 2015 Mar;1(1):40-43. doi: 10.1016/j.sleh.2014.12.010. Epub 2015 Jan 8. — View Citation

Kaul P, Passafiume J, Sargent CR, O'Hara BF. Meditation acutely improves psychomotor vigilance, and may decrease sleep need. Behav Brain Funct. 2010 Jul 29;6:47. doi: 10.1186/1744-9081-6-47. — View Citation

Killgore WD. Effects of sleep deprivation on cognition. Prog Brain Res. 2010;185:105-29. doi: 10.1016/B978-0-444-53702-7.00007-5. — View Citation

Koerten HR, Watford TS, Dubow EF, O'Brien WH. Cardiovascular effects of brief mindfulness meditation among perfectionists experiencing failure. Psychophysiology. 2020 Apr;57(4):e13517. doi: 10.1111/psyp.13517. Epub 2020 Feb 4. — View Citation

Kong SDX, Hoyos CM, Phillips CL, McKinnon AC, Lin P, Duffy SL, Mowszowski L, LaMonica HM, Grunstein RR, Naismith SL, Gordon CJ. Altered heart rate variability during sleep in mild cognitive impairment. Sleep. 2021 Apr 9;44(4):zsaa232. doi: 10.1093/sleep/zsaa232. — View Citation

Krause AJ, Simon EB, Mander BA, Greer SM, Saletin JM, Goldstein-Piekarski AN, Walker MP. The sleep-deprived human brain. Nat Rev Neurosci. 2017 Jul;18(7):404-418. doi: 10.1038/nrn.2017.55. Epub 2017 May 18. — View Citation

Libby DJ, Worhunsky PD, Pilver CE, Brewer JA. Meditation-induced changes in high-frequency heart rate variability predict smoking outcomes. Front Hum Neurosci. 2012 Mar 19;6:54. doi: 10.3389/fnhum.2012.00054. eCollection 2012. — View Citation

Lischke A, Lemke D, Neubert J, Hamm AO, Lotze M. Inter-individual differences in heart rate variability are associated with inter-individual differences in mind-reading. Sci Rep. 2017 Sep 14;7(1):11557. doi: 10.1038/s41598-017-11290-1. — View Citation

Maruthai N, Nagendra RP, Sasidharan A, Srikumar S, Datta K, Uchida S, Kutty BM. Senior Vipassana Meditation practitioners exhibit distinct REM sleep organization from that of novice meditators and healthy controls. Int Rev Psychiatry. 2016 Jun;28(3):279-87. doi: 10.3109/09540261.2016.1159949. Epub 2016 Apr 8. — View Citation

Tang YY, Holzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci. 2015 Apr;16(4):213-25. doi: 10.1038/nrn3916. Epub 2015 Mar 18. — View Citation

Thayer JF, Lane RD. Claude Bernard and the heart-brain connection: further elaboration of a model of neurovisceral integration. Neurosci Biobehav Rev. 2009 Feb;33(2):81-8. doi: 10.1016/j.neubiorev.2008.08.004. Epub 2008 Aug 13. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Error frequency Change: Go-No Go Task	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.	2 months post learning meditation
Secondary	Reaction Time Change: Go-No Go	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.	2 months post learning meditation