Effect of Yoga in Chronic Insomnia

Recruiting now · Not applicable

Conditions studied: Chronic Insomnia

In brief

This study will evaluate the effect of the yoga in participants with chronic insomnia. The primary objective is to determine whether adding yoga to standard care improves insomnia severity, as measured by the Insomnia Severity Index (ISI), compared to standard care alone. The study will also assess changes in sleep architecture using polysomnography and examine dysfunctional beliefs and attitudes about sleep. Secondary objectives include evaluating the effects of yoga on stress biomarkers (salivary cortisol and salivary alpha-amylase) and on somatosensory information processing using quantitative sensory testing. These measures aim to explore possible mechanisms by which yoga may influence insomnia symptoms, including stress modulation and sensory processing changes. This assessor-blinded, randomized controlled trial will enroll 72 participants aged 18-65 years diagnosed with chronic insomnia. Participants will be randomly assigned to one of three groups: (1) Yoga + Standard Care (2) Stretching group + Standard Care (3) Standard Care alone. The yoga group and stretching group will receive an 8-week intervention (2 weeks supervised group sessions, followed by 6 weeks home practice with telemonitoring). Assessments will be performed at baseline, 2 weeks, and 8 weeks. The primary outcome is change in ISI score at 8 weeks. Secondary outcomes include polysomnographic measures, dysfunctional beliefs and attitudes about sleep, depression-anxiety-stress scores, daytime sleepiness, stress biomarker levels, and sensory thresholds

Key facts

Study ID: NCT07419152
Run by: All India Institute of Medical Sciences
People needed: 72
Starts: 2024-08-14
Expected to finish: 2029-03-01
Last updated by the study team: 2026-02-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age:18-65 years
Either gender
Diagnosis of chronic insomnia as per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Ability to understand the study procedures and provide written informed consent Exclusion Criteria
A current diagnosis of any other sleep disorder such as RLS, PLMS, circadian rhythm sleep disorder, narcolepsy, parasomnias
Suicidal ideation
Shift work or trans-meridian travel in last two weeks
Pregnant or lactating females
Excessive caffeine use
History of drug or alcohol abuse
Serious chronic conditions or exacerbation of chronic disorder preventing further participation

Where it is running

All India Institute of Medical Sciences New Delhi — New Delhi, National Capital Territory of Delhi, India (enrolling)

Full record on ClinicalTrials.gov

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