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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12608000526370
Enrollment
15
Registered
2008-10-15
Start date
2008-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 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). Anxi

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).

Sponsors

United Hospitals Bristol
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026