Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
None listed
Sponsors
Central Council For Research in Ayurvedic Science
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participants meeting the DSM 5 diagnostic criteria of Insomnia Disorder (780.52 (G47.00)) 2) Participants with an age group between 60-80 years of either sex. 3) Participants who are ambulatory and clinically stable with or without medication. 4) Participants willing to provide written informed consent for their participation in the study for 3 months. 1. Participants complaining of one (or more) of the following symptoms: a) Difficulty initiating sleep (subjective sleep-onset latency greater than 20-30 minutes). b) Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings (a subjective time awake after sleep onset greater than 20-30 minutes). c) Early-morning awakening with inability to return to sleep (awakening at least 30 minutes before the scheduled time and before total sleep time reaches 6 hours). 2. Participants with clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning due to sleep disturbance. 3. Participants facing sleep difficulty at least 3 nights per week. 4. Participants facing sleep difficulty for at least 3 months. 5. The sleep difficulty occurs despite adequate opportunity for sleep. 6. The insomnia is not better explained by and does not occur exclusively during another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia). 7. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication). 8. Participants with coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia. 5) Participants with subjective complaint of at least one negative daytime consequence attributed to insomnia (e.g., fatigue, mood disturbances). 6) Participants with no history of benzodiazepine intake
Exclusion criteria
Exclusion criteria: 1. Participants with presence of a significant concurrent medical conditions such as malignancies, liver cirrhosis, chronic renal failure or other serious medical conditions which compromises sleep. 2. Participants with diagnosis of any organic brain disease, hemorrhagic diseases, coagulation disorders within 90 days prior to the screening that could interfere with their capacity to participate in the study. 3. Participants with neurological disorders (e.g., dementia, Parkinson disease), mental retardation, or severe cognitive or psychiatric illness, current severe depressive disorder, psychotic disorders, BPAD. 4. Participants with other sleep-wake disorders like narcolepsy, a breathing-related sleep disorder (Epworth Sleepiness Scale greater than 10) 5. Participants with circadian rhythm sleep-wake disorder. 6. Participants with parasomnia, altitude insomnia, transient insomnia etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in scores of Pittsburgh Sleep Quality Index (PSQI)Timepoint: Baseline, 28th, 56th, 84th and 112th Day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in whole night polysomnography (Sleep stages, respiratory effort, airflow, end-tidal CO2, transcutaneous PCO2, oxygen saturation) . Changes in sleep-related biochemical variables (Cortisol, Melatonin, DHEA). Changes in WHOQOL 26 BREF, PHQ-9. Changes in the safety parametersTimepoint: during baseline and at 84th day | — |
Countries
India
Contacts
Public ContactDr Shashidhar Doddamani
Central Council for Research in Ayurveda
Outcome results
None listed