NCT02484963

The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia

Completed NA Last updated 17 May 2018

What this trial tests

NA trial testing Zolpidem in Cirrhosis in 52 participants. Completed in 15 January 2017.

Timeline

15 May 2015

Primary endpoint
15 January 2017

15 January 2017

Quick facts

Lead sponsor	Institute of Liver and Biliary Sciences, India
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	15 May 2015
Primary completion	15 January 2017
Estimated completion	15 January 2017
Sites	1 location across India

Drugs / interventions tested

• Zolpidem (zolpidem) — full drug profile →
• placebo

Conditions studied

• Cirrhosis — all drugs for Cirrhosis →

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 70, any sex, with Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of zolpidem on sleep parameters in patients with cirrhosis and sleep disturbances: A randomized, placebo-controlled trial.
   Sharma MK, Kainth S, Kumar S, Bhardwaj A, et al · · 2019 · cited 25× · PMID 30856689 · DOI 10.3350/cmh.2018.0084