Impairment of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparison to Patients Without Opioid Withdrawal

Completed

• Conditions: Sleep Architecture Under Opioid Medication

• Registration Number: NCT01540890
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

Main of the study is to assess the influence of high-dose opioids on the sleep architecture and patterns of breathing using non-invasive polysomnographic measurements before and after opioid withdrawal in patient who undergo opioid withdrawal independently from the present study. These data will be compared to polysomnographic data of patients under opioid treatment who do not undergo opioid withdrawal as well as to patients without opioid treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• older than 18 year, indication for opioid withdrawal (cohort 1), opioid intake (cohort 1 and 2)

Exclusion Criteria

• plaster allergic reactions, opioid withdrawal (cohort 2), opioid intake (cohort 3)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of an abnormal apnoea-hypnoea index	3 weeks

Secondary Outcome Measures

Name	Time	Method
changes of the sleep duration and architecture	3 weeks

Trial Locations

Locations (1)

Department of Pain Medicine; 🇩🇪 Bochum, Germany