Effect of Yoga in Chronic Insomnia

NCT07419152 | Recruiting DMC

• 1 other identifier: D-642
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Insomnia

Keywords

Insomnia; Hyperarousal; Yoga-intervention; Sensory information processing; Microarousals

Outcome Measures

Primary Outcomes (1)

• Severity of insomnia: Insomnia severity index (ISI)

  Primary outcome: Severity of insomnia as assessed by Insomnia Severity Index (ISI), Score from 0-7: No clinically significant insomnia, 8-14: Subthreshold (mild) insomnia, 15-21: Moderate insomnia, 22-28: Severe insomnia. An increase in mean insomnia severity of the group, 8 weeks post commencement of intervention.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• Change in Sleep Architecture

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (6)

• Dysfunctional beliefs about sleep

  From enrollment to the end of treatment at 8 weeks

• Level of salivary cortisol

  From enrollment to the end of treatment at 8 weeks

• Quantitative sensory testing

  From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Yoga Group

EXPERIMENTAL

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.

Behavioral: Yoga-intervention

Stretching Group

ACTIVE COMPARATOR

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

Behavioral: Stretching Exercises

Control group (No intervention)

NO INTERVENTION

Standard Care Alone: Pharmacological and/or CBT without exercise intervention.

Interventions

Yoga-intervention BEHAVIORAL

Yoga-based mind-body program based on the Common Yoga Protocol (CYP) developed by the Ministry of AYUSH, Government of India. The protocol included a standardized sequence of yogic practices such as loosening exercises, asanas, pranayama, and relaxation/meditation techniques. A modified version of the Common Yoga Protocol with modification limited to the duration of practice, while maintaining the structure and components of the original protocol. Participants practiced yoga for 5 days per week, for a total duration of 8 weeks, 2 weeks under the supervision of a trained yoga instructor and 6 weeks of self-training which will be monitored through zoom calls by the researcher and yoga instructor.

Yoga Group

Stretching Exercises BEHAVIORAL

Participants in the stretching group will practise supervised stretching exercise protocol which include overhead trunk stretch, goal post stretch, rear deltoid stretch, wrist stretch, chair assisted hamstring stretch, leg criss-cross oblique stretch, prone lying quadriceps stretch, crescent stretch (hip flexors), knee to chest stretch exercises for continuous 2 weeks followed by 6 weeks of self-training which will be monitored through zoom calls by the researcher and yoga instructor.

Stretching Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Science and Technology, Government of India: collaborator
• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences New Delhi

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

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Model Details: Participants will be randomly assigned to one of three groups: (1) Yoga + Standard Care, (2) Stretching group + Standard Care, or (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

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 18, 2026
• Study Start: August 14, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2025-12

Locations

IN (1)