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Effect of Yoga in Chronic Insomnia: A Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
India
All India Institute of Medical Sciences New Delhi
RECRUITING
New Delhi
Time Frame
Start Date: 2024-08-14
Estimated Completion Date: 2029-03
Participants
Target number of participants: 72
Treatments
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.
Active_comparator: Stretching Group
Stretching group + Standard Care: Stretching protocol is matched for duration and supervision plus standard care.
No_intervention: Control group (No intervention)
Standard Care Alone: Pharmacological and/or CBT without exercise intervention.
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences
Collaborators: Department of Science and Technology, Government of India

This content was sourced from clinicaltrials.gov