CirrhosisNCT02484963
The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
A study testing Zolpidem in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2015to 15 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Clinical, Biochemical, Radiological ,Histological evidence of cirrhosis of all etiology
- Child A and B cirrhosis (for intervention part)
- Cirrhosis patients giving h/o persistent sleep disturbances (PSQI≥5)
- Child A, B and C cirrhosis (for observational part)
Who cannot join
- Active alcohol intake or intake within 1 month of enrollment
- Active substance abuse or intake within 1 month of enrollment
- Known psychiatric and neurological disorders
- Patient using antidepressant, anticonvulsants, other hypnotics
- Pregnancy or lactation
- Overt hepatic encephalopathy (grade 2,3,4)
Show all 11Show fewer
- Child C cirrhosis (for intervention part)
- Acute decompensated state of CLD (Chronic Liver Disease) - GastroIntestinal bleed, increased jaundice, HE (Hepatic Encepahlopahty) , SBP (Spontaneous Bacterial Peritonitis).
- HCC (HepatoCellular Carcinoma) with portal vein thrombosis
- Acute febrile illness/ acute infection
- Post TIPS (Transjugular Intrahepatic Portosystemic shunt)patient
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
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.
- Conditions
- Cirrhosis
- Being tested
- Zolpidem, placebo
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| zolpidem | Experimental | Tablet zolpidem 5mg once daily will be given for 4 weeks Receives: Drug: Zolpidem |
| Placebo | Placebo comparator | One tablet of placebo will be given for 4 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time
Measured: 4 weeks
Secondary outcomes (4)
Precipitation of Hepatic encephalopathy with Zolpidem
Measured: 4 weeks
Increase in daytime sleepiness with zolpidem as measured by ESS
Measured: 4 weeks
Improvement in sleep efficiency after treatment
Measured: 4 weeks
Reduction in periodic limb movements after treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start15 May 2015
- Primary completion15 Jan 2017
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484963
- Sponsor's protocol ID
- ILBS-Insomnia-001
- Status last verified
- Jun 2016
- First submitted
- 22 May 2015
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia
- ClinicalTrials.gov ID
- NCT02484963
- Acronym / sponsor ID
- ILBS-Insomnia-001
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 May 2015 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zolpidem | Experimental | Drug: ZolpidemTablet zolpidem 5mg once daily will be given for 4 weeks |
| Placebo | Placebo comparator | Drug: placeboOne tablet of placebo will be given for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 70 years
- Clinical, Biochemical, Radiological ,Histological evidence of cirrhosis of all etiology
- Child A and B cirrhosis (for intervention part)
- Cirrhosis patients giving h/o persistent sleep disturbances (PSQI≥5)
- Child A, B and C cirrhosis (for observational part)
Key exclusion criteria (11 listed)
- Active alcohol intake or intake within 1 month of enrollment
- Active substance abuse or intake within 1 month of enrollment
- Known psychiatric and neurological disorders
- Patient using antidepressant, anticonvulsants, other hypnotics
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolpidem | Drug | zolpidem |
| placebo | Drug | Placebo |
Primary outcome
Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time
Time frame: 4 weeks
4 secondary outcomes
Precipitation of Hepatic encephalopathy with Zolpidem
Time frame: 4 weeks
Increase in daytime sleepiness with zolpidem as measured by ESS
Time frame: 4 weeks
Improvement in sleep efficiency after treatment
Time frame: 4 weeks
Reduction in periodic limb movements after treatment
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zolpidem in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in quality of sleep in CHILD A/B cirrhosis patients after 4 weeks as measured by total sleep time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.