Effect of Yoga in Chronic Insomnia

Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: Yoga-intervention; Behavioral: Stretching Exercises

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110029
      • Recruiting
      • All India Institute of Medical Sciences New Delhi
      • Contact: Nasreen Akhtar Additional Professor, MD; PhD; Phone Number: 91-9899264164; Email: drnasreenakhtar@aiims.edu
      • Contact: Ananya Dwivedi; Phone Number: 91-7081012416; Email: ananyadwivedi0698@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Group; 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; 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.
Active Comparator: Stretching Group; Stretching group + Standard Care: Stretching protocol is matched for duration and supervision plus standard care.	Behavioral: Stretching Exercises; 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.
No Intervention: Control group (No intervention); Standard Care Alone: Pharmacological and/or CBT without exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Architecture	Wake after sleep onset- Polysomnography	From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysfunctional beliefs about sleep	The Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a self-report questionnaire designed to identify unhelpful thoughts and misconceptions that contribute to the development and persistence of insomnia. The commonly used DBAS-16 consists of 16 items that assess maladaptive beliefs related to the consequences of insomnia, worry and helplessness about sleep, unrealistic sleep expectations, and beliefs about sleep medication. Each item is rated on a Likert scale, typically from 0 to 10, with higher scores indicating more strongly endorsed dysfunctional beliefs about sleep.	From enrollment to the end of treatment at 8 weeks
Level of salivary cortisol	Salivary cortisol as stress marker will be estimated	From enrollment to the end of treatment at 8 weeks
Quantitative sensory testing	Cortical sensory processing based on quantitative sensory testing	From enrollment to the end of treatment at 8 weeks
Change in sleep parameters	Sleep latencies	From enrollment to the end of treatment at 8 weeks
Change in sleep duration	Change in duration of different sleep stages	From enrollment to the end of treatment at 8 weeks
Salivary alpha amylase	Salivary alpha amylase as stress marker	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences
• Collaborators: Department of Science and Technology, Government of India

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Insomnia; Hyperarousal; Microarousals; Yoga-intervention; Sensory information processing
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise; Muscle Stretching Exercises
• Other Study ID Numbers: D-642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No