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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01540890
First received: February 23, 2012
Last updated: March 17, 2014
Last verified: March 2014

February 23, 2012
March 17, 2014
November 2011
December 2012   (final data collection date for primary outcome measure)
frequency of an abnormal apnoea-hypnoea index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
frequency of an abnormal apnoe-hypnoe index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01540890 on ClinicalTrials.gov Archive Site
changes of the sleep duration and architecture [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
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Impairment of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparison to Patients Without Opioid Withdrawal
Not Provided

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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

inpatients with chronic pain

Sleep Architecture Under Opioid Medication
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  • withdrawal
    patients who undergo an opioid withdrawal
  • opioids
    patients on opioid medication without withdrawal
  • opioid-free
    patients with chronic pain without opioid medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2013
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01540890
Polysom2012
No
Christoph Maier, Prof. Dr., Ruhr University of Bochum
Ruhr University of Bochum
Not Provided
Not Provided
Ruhr University of Bochum
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP