Impairement of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparisson to Patients Without Opioid Withdrawal
This study is currently recruiting participants.
Verified February 2012 by Ruhr University of Bochum
Sponsor:
Ruhr University of Bochum
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01540890
First received: February 23, 2012
Last updated: February 28, 2012
Last verified: February 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2012 | ||||
| Last Updated Date | February 28, 2012 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
frequency of an abnormal apnoe-hypnoe index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01540890 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
changes of the sleep duration and architecture [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impairement of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparisson to Patients Without Opioid Withdrawal | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | inpatients with chronic pain |
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| Condition ICMJE | Sleep Architecture Under Opioid Medication | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | February 2013 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01540890 | ||||
| Other Study ID Numbers ICMJE | Polysom2012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christoph Maier, Ruhr University of Bochum | ||||
| Study Sponsor ICMJE | Ruhr University of Bochum | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Ruhr University of Bochum | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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