Chronic InsomniaNCT07419152
Effect of Yoga in Chronic Insomnia
A study testing Yoga-intervention and Stretching Exercises in people with Chronic Insomnia, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Yoga-intervention and Stretching Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 14 Aug 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences New Delhi
New Delhi, National Capital Territory of Delhi, 110029
Nasreen Akhtar Additional Professor, MD; PhD, 91-9899264164, drnasreenakhtar@aiims.edu
Ananya Dwivedi, 91-7081012416, ananyadwivedi0698@gmail.com
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Chronic Insomnia
- Being tested
- Yoga-intervention, Stretching Exercises
- Keywords
- Insomnia, Hyperarousal, Yoga-intervention, Sensory information processing, Microarousals
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-interventionBehavioural
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 ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Yoga-intervention |
| Stretching Group | Active comparator | Stretching group + Standard Care: Stretching protocol is matched for duration and supervision plus standard care. Receives: Behavioral: Stretching Exercises |
| Control group (No intervention) | No intervention | Standard Care Alone: Pharmacological and/or CBT without exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
Change in Sleep Architecture
Wake after sleep onset- Polysomnography
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start14 Aug 2024
- Primary completionAug 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Science and Technology, Government of India
- Responsible party
- Principal investigator, Nasreen Akhtar, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419152
- Sponsor's protocol ID
- D-642
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07419152
- Acronym / sponsor ID
- D-642
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia, Hyperarousal, Yoga-intervention, Sensory information processing, Microarousals
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Department of Science and Technology, Government of India
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Behavioral: Yoga-interventionYoga + 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 | Active comparator | Behavioral: Stretching ExercisesStretching group + Standard Care: Stretching protocol is matched for duration and supervision plus standard care. |
| Control group (No intervention) | No intervention | –Standard Care Alone: Pharmacological and/or CBT without exercise intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga-interventionYoga-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. | Behavioural | Yoga Group |
| Stretching ExercisesParticipants 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. | Behavioural | Stretching Group |
Primary outcome
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.
1 secondary outcome
Change in Sleep Architecture
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
All India Institute of Medical Sciences New Delhi
New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga-intervention and Stretching Exercises in people with Chronic Insomnia, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of insomnia: Insomnia severity index (ISI) (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.