RecruitingACTRN12608000526370

Sleep electroencephalogram (EEG) recordings in interferon-alpha treated hepatitis C patients – Pilot Study

A study to evaluate the effects of Interferon-alpha treatment on sleep electroencephalogram (EEG) changes in hepatitis C patients


Sponsor

United Hospitals Bristol

Enrollment

15 participants

Start Date

Jul 1, 2008

Study Type

Observational

Conditions

Summary

Hepatitis C is a condition that is often treated successfully with interferon. However, interferon treatment can sometimes cause mood problems, including depression. One possible reason for this is that interferon may affect a chemical called serotonin in the brain, which governs mood and sleep. No-one has studied changes in the brain’s serotonin system during interferon treatment. Discovering how interferon causes depression will help us to provide more effective treatment, or prevention, of this for future patients undergoing interferon treatment. It may also help us discover what is happening to the brain in other forms of depression. The purpose of this study is to measure the brain activity during sleep, before and during interferon treatment. This will give us a measure of how the brain’s serotonin system changes during interferon treatment and whether this can be linked to the development of depression. Hypothesis: there will be a shorter period until REM (dreaming sleep) and greater sleep fragmentation (more broken sleep) when patient are taking interferon compared to before treatment. Secondary hypothesis: the degree of sleep change will correlate with worsening scores upon mood, anxiety and irritability scales. Further hypothesis: the degree of sleep change may predict later episodes of depression further on in treatment


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people with hepatitis C who are receiving interferon treatment. Interferon can sometimes cause depression and sleep problems. Researchers believe interferon may affect serotonin, a brain chemical that controls mood and sleep patterns. This pilot study records brain activity during sleep using an EEG (brainwave monitor) before and during interferon treatment to look for early signs of changes that might predict who develops depression during treatment. You may be eligible if: - You have been diagnosed with hepatitis C - You are receiving or about to start interferon alpha treatment - You are 18 years of age or older You may NOT be eligible if: - You have a current mental illness or drug/alcohol problem - You have a history of schizophrenia or bipolar disorder - You have an unstable medical illness - You are taking medication that affects sleep (such as antidepressants) - You currently work night shifts Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Mood and brain serotonin functioning changes with interferon treatment in hepatitis C patients. 1) Mood changes will be assessed by: a computerised psychiatric diagnostic programme will also be admi

Mood and brain serotonin functioning changes with interferon treatment in hepatitis C patients. 1) Mood changes will be assessed by: a computerised psychiatric diagnostic programme will also be administered; the CIS-R (Lewis et al., 1992) is a computerised interview schedule that establishes the nature and severity of neurotic symptoms experienced over the previous 7 days and identifies the presence of neurosis. Additional rating scales will be taken. Mood: Beck Depression Inventory (BDI). Anxiety: Spielberger state anxiety inventory (SSAI) and Panic State Inventory (PSI). Irritability: Spielberger state anger expression inventory (STAXI) and Visual Analogue Scales (VAS-each category is measured on 100mm line, anchored from 0: ‘‘not at all’’ to 100: “the most ever”). Sleep: Bristol Sleep Profile, short clinical interview to elicit any sleep disorder. Brain serotonin functioning will be measured by changes in sleep electroencephalogram architecture: priamary measures are reduced rapid eye movement latency and increased sleep fragmentation. Secondary measures will be: increased rapid eye movement percentage of sleep, reduced stage 2 sleep 2) The study duration will be approximately 7 weeks; one week prior to staring interferon and after six weeks of interferon treatment.Each assessment lasts for approximately 1.5-2hours for the questionnaires and computer programing. The sleep EEG recording runs overnight (approximately 8 hours) for each assessment session. In addition psychiatric diagnosis will be collected for all patients the treating team feel may be suffering from a psychiatric illness for the duration of their interferon treatment (usually six or twelve months).


Locations(1)

Bristol, United Kingdom

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ACTRN12608000526370