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All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index will undergo polysomnography and will be randomised to two groups after fulfilling all inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed time daily. The treatment will be continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and polysomnography. All patients will be advised regarding sleep hygiene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zolpidem | Experimental | Tablet zolpidem 5mg once daily will be given for 4 weeks |
|
| Placebo | Placebo Comparator | One tablet of placebo will be given for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Precipitation of Hepatic encephalopathy with Zolpidem | 4 weeks | |
| Increase in daytime sleepiness with zolpidem as measured by ESS | 4 weeks | |
| Improvement in sleep efficiency after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 4 weeks |
| Reduction in periodic limb movements after treatment | 4 weeks |