Effects Of Hare Krishna Mahamantra On Treatment Of Sleep related problems

Not Applicable

Completed

• Conditions: Health Condition 1: null- Primary Insomnia

• Registration Number: CTRI/2017/06/008753
• Lead Sponsor: nil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-19
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

(1) Subjects who meet diagnostic criteria for PI and effectively screened through structured psychiatric and sleep interviews (Williams et al., 1992; First et al., 1996)

(2) Subjects who have no notable physiological illnesses affecting sleep

(3)Subjects who have a mean WASO(Wake after sleep onset) and/or SOL(Sleep Onset Latency) >30 minutes in a week of sleep log monitoring

(4) Subjects who have complaints of daytime fatigue and sleepiness

(5) Subjects who have Insomnia Severity Index >15

(6) Subjects with sleep disturbance of at least 3 nights per week for at least 6 months

References

Williams, J. B., Gibbon, M., First, M. B. et al. The structured clinical interview for DSM-III-R (SCID): II. Multisite test-retest reliability. Arch. Gen. Psychiatry, 1992, 49: 630-636.

First, M., Spitzer, R., Williams, J., & Gibbon, M. Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). New York: Biomedics Research Department, New York State Psychiatric Institute, 1996.

Edinger, J. D., Bonnet, M. H., Bootzin, R. R. et al. Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group. Sleep, 2004, 27:1567-1596.

Exclusion Criteria

(1) Reported alcohol or drug abuse or unstable current medication in the past year, non-clinically noteworthy insomnia (Edinger et al., 2004)

(2) Could not commit for enough time to participate in the study or disagree to take part

(3) Subjects with Total Sleep Time (TST (Total Sleep time) > 6 hrs), Sleep efficiency (SE > 85%), WASO >60 mins in a week of sleep log monitoring, ISI (Insomnia severity index) >22, and a sustained stable sleep period between 22:00 and 08:00 hrs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Final sleep diary measures used to assess insomnia status post intervention. <br/ ><br>2) Polysomnography indicators of insomnia post treatment.Timepoint: 3 Months 15 days

Secondary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index (PSQI), ISI(Insomnia Severity Index), DBAS(Dysfunctional Beliefs and Attitudes about <br/ ><br>Sleep), HAS(Hyper-arousal Scale), Epworth Sleepiness Scale (ESS) <br/ ><br>Timepoint: 3 Months 15 days