Effect of Yoga in Chronic Insomnia

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Treatment

Stretching Exercises

Yoga-intervention

Clinical Study ID

NCT07419152

D-642

Ages 18-65
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Stretching Exercises

August 14, 2024

March 31, 2029

Study Description

Chronic insomnia is a common sleep disorder characterized by difficulty initiating or maintaining sleep, or experiencing non-restorative sleep, despite adequate opportunity for sleep, with associated daytime impairment. Current treatments, such as pharmacotherapy and cognitive behavioral therapy (CBT), have limitations including side effects, limited accessibility, and adherence challenges.

Yoga, an ancient mind-body practice, incorporates postures, breathing exercises, and meditation, and may positively influence insomnia by modulating stress responses, improving autonomic regulation, and altering sensory processing. The Common Yoga Protocol, developed by the Ministry of AYUSH, is a structured regimen combining sustained postures, breath control, and meditation.

This randomized controlled trial will assess the effect of adding the yoga protocol to standard care in participants with chronic insomnia. The primary outcome is change in insomnia severity (ISI) after 8 weeks of the intervention. Secondary outcomes include changes in sleep architecture (polysomnography), dysfunctional beliefs and attitudes about sleep, mood and anxiety symptoms (DASS-21), daytime sleepiness (Epworth Sleepiness Scale), stress biomarkers (salivary cortisol, salivary alpha-amylase), and somatosensory information processing (quantitative sensory testing after 8 weeks of the intervention.

Seventy-two participants aged 18-65 years meeting DSM-IV-TR criteria for chronic insomnia will be randomly assigned to one of three groups:

Yoga + Standard Care: Common Yoga Protocol (8 weeks: 2 weeks supervised, 6 weeks home practice with telemonitoring) plus pharmacological and/or CBT-based standard care.

Stretching group + Standard Care: Stretching group matched for duration and supervision plus standard care.

Standard Care Alone: Pharmacological and/or CBT without exercise intervention. Assessments will be conducted at baseline, 2 weeks, and 8 weeks. The trial is assessor-blinded, uses permuted block randomization, and will follow CONSORT and SPIRIT guidelines. Results may investigate the role of yoga as an adjunctive therapy for chronic insomnia.

Connect with a study center

All India Institute of Medical Sciences New Delhi
New Delhi 1261481, National Capital Territory of Delhi 1273293 110029
India
Active - Recruiting

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