Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Adding yoga to usual care for adults with chronic insomnia

Official title: Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial

Run by All India Institute of Medical Sciences · NCT07419152 · Data updated 2026-11-12

This trial will test whether doing a structured yoga program alongside usual care helps adults (18–65) with chronic insomnia sleep better than usual care alone.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment72 (estimated)
SponsorAll India Institute of Medical Sciences
Academic / other
Locations1 site (New Delhi, National Capital Territory of Delhi)
StatusRecruiting
StartedAugust 14, 2024
Main results expectedAugust 2028
Study endsMarch 2029
Registry record updatedFebruary 18, 2026
Trial IDNCT07419152 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 who meet DSM-IV-TR criteria for chronic insomnia, can attend in-person sessions at the study site, and can give informed consent are ideal candidates.

Probably not a fit

People with other primary sleep disorders (e.g., RLS, narcolepsy), recent shift work or trans-meridian travel, active substance abuse, serious unstable medical conditions, or who are pregnant or lactating are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an assessor-blinded, randomized controlled trial enrolling 72 adults aged 18–65 with DSM-IV-TR chronic insomnia, randomized to a yoga plus standard care group, a stretching control, or standard care alone. The intervention uses the Common Yoga Protocol over 8 weeks and compares changes in insomnia severity (Insomnia Severity Index) between groups. Secondary outcomes include overnight polysomnography to examine sleep architecture, measures of mood and daytime sleepiness, stress biomarkers (salivary cortisol and alpha-amylase), dysfunctional beliefs about sleep, and quantitative sensory testing to probe somatosensory processing. The trial aims to link clinical sleep changes with physiological and sensory mechanisms to understand how yoga might influence insomnia symptoms.

Why it matters

Potential benefit: If effective, adding yoga could reduce insomnia symptoms and improve sleep quality and related stress measures without medication.

How similar studies have gone: Previous randomized and nonrandomized studies of yoga for insomnia and sleep disturbance have reported modest improvements in sleep and stress in some trials, but results are mixed and not yet conclusive.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria

* 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's running

  • All India Institute of Medical Sciences New Delhi
    New Delhi, National Capital Territory of Delhi, India
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.