Effect of Yoga in Chronic Insomnia

February 16, 2026 updated by: Nasreen Akhtar, All India Institute of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Sleep Architecture
Time Frame: From enrollment to the end of treatment at 8 weeks
Wake after sleep onset- Polysomnography
From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 8 weeks
Level of salivary cortisol
Time Frame: From enrollment to the end of treatment at 8 weeks
Salivary cortisol as stress marker will be estimated
From enrollment to the end of treatment at 8 weeks
Quantitative sensory testing
Time Frame: From enrollment to the end of treatment at 8 weeks
Cortical sensory processing based on quantitative sensory testing
From enrollment to the end of treatment at 8 weeks
Change in sleep parameters
Time Frame: From enrollment to the end of treatment at 8 weeks
Sleep latencies
From enrollment to the end of treatment at 8 weeks
Change in sleep duration
Time Frame: From enrollment to the end of treatment at 8 weeks
Change in duration of different sleep stages
From enrollment to the end of treatment at 8 weeks
Salivary alpha amylase
Time Frame: From enrollment to the end of treatment at 8 weeks
Salivary alpha amylase as stress marker
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
All India Institute of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Science and Technology, Government of India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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