Effect of Yoga in Chronic Insomnia

ConditionChronic Insomnia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAll India Institute of Medical Sciences

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

72 Participants

are divided into 3 treatment groups

Group A: Yoga GroupExperimental treatment 1 intervention

Group B: Stretching GroupActive comparator 1 intervention

Group C: Control group (No intervention)No intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame