| NCT ID | NCT07419152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | All India Institute of Medical Sciences |
| Condition | Chronic Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2024-08-14 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07419152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07419152 currently recruiting?
Yes, NCT07419152 is actively recruiting participants. Visit ClinicalTrials.gov or contact All India Institute of Medical Sciences to inquire about joining.
Where is the NCT07419152 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT07419152 clinical trial?
NCT07419152 is sponsored by All India Institute of Medical Sciences. The trial plans to enroll 72 participants.
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