Effect of yoga therapy on chronic insomnia

Phase 2

Recruitment & Eligibility

Inclusion Criteria

Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition

criteria for Insomnia Disorder, as follows:

1. Complains of dissatisfaction with nighttime sleep, in the form of difficulty

staying asleep and/or awakening earlier in the morning than desired

despite adequate opportunity for sleep (Note that if the complaint is

limited to difficulty initiating sleep, the subject is not eligible)

2. Frequency of complaint >=3 times per week

3. Duration of complaint >=3 months

4. Associated with complaint of daytime impairment

Exclusion Criteria

A current diagnosis of any other sleep disorder such as OSA, RLS, PLMS,

circadian rhythm sleep disorder, narcolepsy, parasomnias

2. Suicidal ideation

3. Any sleep pattern disturbing factor such as Shift work or child less than one

year at home or transmeridian travel in last two weeks

4. Pregnant or lactating females

5. Excessive caffeine use (habitually consumes caffeine-containing beverages

after 18:00 and is unwilling to forego caffeine after18:00 for the duration of

his/her participation in the study

6. History of drug or alcohol abuse

Primary Outcome Measures

Name	Time	Method
Severity of insomnia as assessed by Insomnia Severity Index, an <br/ ><br>increase in mean insomnia severity of the group, 12 weeks post commencement of <br/ ><br>intervention.Timepoint: 0 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Exploratory objectives <br/ ><br>To assess the effect of 8 weeks of yoga practice in chronic insomnia patients, of: <br/ ><br>1. Microarousals, Latency to persistent sleep, Wake After Sleep Onset and sleep <br/ ><br>architecture as determined by polysomnography <br/ ><br>2. Subjective sleep quality <br/ ><br>3. Autonomic functions-heart rate variability, blood pressure variability <br/ ><br>4. Stress levels- Salivary cortisol and serum catecholamines <br/ ><br>5. Somato-sensory information processing as determined by quantitative sensory <br/ ><br>testingTimepoint: 0 and 12 weeks;To assess the impact of yoga in addition to standard of care on daytime dysfunction in <br/ ><br>patients of chronic insomnia.Timepoint: 0 and 12 weeks