Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Common yoga protocol by AYUSH in addition to Standard of care: Common yoga protocol in addition to Standard of care â?? Medications with or without
Cognitive behaviour therapy for durat
Sponsors
Department of Science and Technology
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of insomnia as assessed by Insomnia Severity Index, an increase in mean insomnia severity of the group, 12 weeks post commencement of intervention.Timepoint: 0 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory objectives To assess the effect of 8 weeks of yoga practice in chronic insomnia patients, of: 1. Microarousals, Latency to persistent sleep, Wake After Sleep Onset and sleep architecture as determined by polysomnography 2. Subjective sleep quality 3. Autonomic functions-heart rate variability, blood pressure variability 4. Stress levels- Salivary cortisol and serum catecholamines 5. Somato-sensory information processing as determined by quantitative sensory testingTimepoint: 0 and 12 weeks;To assess the impact of yoga in addition to standard of care on daytime dysfunction in patients of chronic insomnia.Timepoint: 0 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Nasreen Akhtar
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed