Adding yoga to usual care for adults with chronic insomnia
Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT07419152 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New Delhi, National Capital Territory of Delhi
- All India Institute of Medical Sciences New Delhi — New Delhi, National Capital Territory of Delhi, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.