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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:
ClinicalTrials.gov Identifier:
NCT01540890
First Posted: February 29, 2012
Last Update Posted: March 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
February 23, 2012
February 29, 2012
March 18, 2014
November 2011
December 2012   (Final data collection date for primary outcome measure)
frequency of an abnormal apnoea-hypnoea index [ Time Frame: 3 weeks ]
frequency of an abnormal apnoe-hypnoe index [ Time Frame: 3 weeks ]
Complete list of historical versions of study NCT01540890 on ClinicalTrials.gov Archive Site
changes of the sleep duration and architecture [ Time Frame: 3 weeks ]
Same as current
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Not Provided
 
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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01540890
Polysom2012
No
Not Provided
Not Provided
Christoph Maier, Prof. Dr., Ruhr University of Bochum
Ruhr University of Bochum
Not Provided
Not Provided
Ruhr University of Bochum
March 2014