Sleep electroencephalogram (EEG) recordings in interferon-alpha treated hepatitis C patients – Pilot Study
Not Applicable
Recruiting
- Conditions
- Mood side effects of interferon alpha treatmentMood effects of interferon treatment of hepatitis C patientsMental Health - Depression
- Registration Number
- ACTRN12608000526370
- Lead Sponsor
- nited Hospitals Bristol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Hepatitis C, receiving interferon alpha treatment.
Exclusion Criteria
Current mental illness or drug/alcohol abuse at baseline. History of schizophrenia or bipolar affective disorder. Current unstable medical illness. Taking medicine that affect sleep EEG measures (antidepressants). Current occupational history of nightshift working
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep EEG changes: Rapid Eye Movement latency and sleep fragmentation[Baseline and 6 weeks.]
- Secondary Outcome Measures
Name Time Method Mood changes: Depression, Becks Depression Inventory, visual analogue scales.[baseline and 6 weeks];Mood changes: anxiety, speilberger state/trait anxiety inventory, panic state inventory, visual analogue scales[Baesline and 6 weeks];Mood changes: irritability, spielberger state/trait anger expression inventory, visual analogue scales.[Baseline and six weeks.];Psychiatric diagnosis: revised clinical interview schedule (CIS-R), also clinical diagnosis by a study psychiatrist[Baseline and week 6. Any timepoint for duration of interferon treatment (the duration of interferon treatment is decided by the treating team independant from the study. It is usually either 6 months or 12 months duration depending upon the genotype of hepatitis C and the early response, measured by plasma viral load, to treatment.]