Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07419152

Effect of Yoga in Chronic Insomnia

Led by All India Institute of Medical Sciences · Updated on 2026-02-18

72

Participants Needed

1

Research Sites

237 weeks

Total Duration

On this page

Sponsors

A

All India Institute of Medical Sciences

Lead Sponsor

D

Department of Science and Technology, Government of India

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Effect of Yoga in Chronic Insomnia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Any gender
  • Diagnosis of chronic insomnia according to DSM-IV-TR
  • Ability to understand study procedures and provide written consent
Not Eligible

You will not qualify if you...

  • Diagnosis of other sleep disorders such as restless legs syndrome, periodic limb movement syndrome, circadian rhythm sleep disorder, narcolepsy, or parasomnias
  • Suicidal thoughts
  • Shift work or travel across time zones within the last two weeks
  • Pregnant or breastfeeding women
  • Excessive caffeine consumption
  • History of drug or alcohol abuse
  • Serious or worsening chronic medical conditions that prevent participation

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Trial Site Locations

Total: 1 location

1

All India Institute of Medical Sciences New Delhi

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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