NCT05026541

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

July 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

July 19, 2021

Last Update Submit

April 16, 2026

Conditions

Keywords

sleepsleep disordersleep deprivationMeditationShoonya meditation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reaction Time Change: Go-No Go

    2 months post learning meditation

Study Arms (3)

Nap Practitioners

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

Behavioral: Nap Practitioners

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

Control Meditators

Control subjects will be individuals that have learned the prerequisite meditation to Shoonya meditation. This meditation is called Shambhavi Mahamudra Kriya. Control subjects will not learn Shoonya meditation while they are participating in the study. One weekend of data collection will occur at baseline.

Interventions

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

Nap Practitioners

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

Shoonya Meditators

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults recruited from across the United States.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (14)

  • 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.

    PMID: 29132973BACKGROUND
  • 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.

    PMID: 29073412BACKGROUND
  • 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.

    PMID: 31685950BACKGROUND
  • 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.

    PMID: 28515433BACKGROUND
  • 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.

    PMID: 25783612BACKGROUND
  • 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.

    PMID: 28118405BACKGROUND
  • 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.

    PMID: 20670413BACKGROUND
  • 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.

    PMID: 27055575BACKGROUND
  • 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.

    PMID: 21075236BACKGROUND
  • 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.

    PMID: 18771686BACKGROUND
  • 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.

    PMID: 28912591BACKGROUND
  • 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.

    PMID: 33306103BACKGROUND
  • 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.

    PMID: 22457646BACKGROUND
  • 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.

    PMID: 32020660BACKGROUND

MeSH Terms

Conditions

Sleep DeprivationSleep Wake Disorders

Condition Hierarchy (Ancestors)

DyssomniasNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Balachundhar Subramaniam, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 30, 2021

Study Start

September 12, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations