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NCT Number: NCT07419152

Effect of Yoga in Chronic Insomnia

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

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Severity of insomnia: Insomnia severity index (ISI)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

Secondary outcomes

  1. Change in Sleep Architecture

    Time frame: From enrollment to the end of treatment at 8 weeks

    Wake after sleep onset- Polysomnography

Other outcomes

  1. Dysfunctional beliefs about sleep

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  2. Level of salivary cortisol

    Time frame: From enrollment to the end of treatment at 8 weeks

    Salivary cortisol as stress marker will be estimated

  3. Quantitative sensory testing

    Time frame: From enrollment to the end of treatment at 8 weeks

    Cortical sensory processing based on quantitative sensory testing

  4. Change in sleep parameters

    Time frame: From enrollment to the end of treatment at 8 weeks

    Sleep latencies

  5. Change in sleep duration

    Time frame: From enrollment to the end of treatment at 8 weeks

    Change in duration of different sleep stages

  6. Salivary alpha amylase

    Time frame: From enrollment to the end of treatment at 8 weeks

    Salivary alpha amylase as stress marker

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Collaborators

  • Department of Science and Technology, Government of India

Registry information

Official study title

Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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