Cirrhosis, sleep disorders
Conditions
Interventions
Study setting: Gastroenterology & hepatology clinic of the Department of Medicine, University of Kelaniya Located at Colombo North Teaching Hospital Ragama, Sri Lanka.
The subjects of the study will
Sponsors
Prof. P Arjuna de Silva
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 years and above 2. Patients with a diagnosis of cirrhosis with at least two of the following: compatible clinical features, biochemical evidence or histological evidence 3. Severity of cirrhosis falling under Child-Turcotte-Pugh categories A and B
Exclusion criteria
Exclusion criteria: 1. Patients with obstructive sleep apnoea diagnosed by the following criteria will be excluded (a) neck circumference >17 inches for men and >16 inches for women and (b) Positive Berlin questionnaire 2. Having evidence of moderate to severe depression on Beck Depression Inventory (score >20) 3. Other ongoing conditions that affects the central nervous system and sleep patterns including recent cerebrovascular events (within 3 months), uremia 4. Patients who have consumed alcohol within the last 6 weeks or continue to use alcohol 5. Patients with other diseases that interfere with sleep including chronic diarrhoeal conditions, chronic airway disease 6. Cirrhosis of Child Turcotte Pugh class C 7. Presence of hepatic encephalopathy (HE) (Grade II to IV according to West Haven criteria) 8. Patients who complain of having moderate to severe pruritus that interferes with sleep 9. Patients who are on drugs that are directly known to reduce or increase sleep (e.g. antihistamines) 10. Patients who are continuing to use tobacco (known to reduce melatonin levels in blood) 11. As this study has a significant number of interviewer administered tools and in the absence of a native Tamil speaking researcher in the team, exclusively Tamil speaking patients will be excluded 12. Patients with cognitive or psychiatric impairment who are unable to provide an informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in sleep quality index [Pittsburgh sleep quality index (PSQI)] from baseline scores. [Time point: at the end of 2 weeks of drug therapy and after 1 week of washout] | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in sleep determined by the Epworth sleepiness scale score at baseline [Time point: at the end of 2 weeks of drug therapy and after 1 week of washout] Improvement in quality of life as assessed by the Short Form Liver Disease Quality of Life Questionnaire (SF-36) score at baseline [Time point: at the end of 2 weeks of drug therapy and after 1 week of washout] Improvement in hepatic encephalopathy as determined by the Clinical Hepatic Encephalopathy Staging Scale (CHESS) score from baseline [Time point: at the end of 2 weeks of drug therapy and after 1 week of washout] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. P Arjuna de Silva
Professor in Medicine & Consultant Physician
Outcome results
None listed