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

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

Sleep Architecture Under Opioid Medication

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • frequency of an abnormal apnoea-hypnoea index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes of the sleep duration and architecture [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
patients who undergo an opioid withdrawal
patients on opioid medication without withdrawal
patients with chronic pain without opioid medication


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
inpatients with chronic pain

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01540890

Department of Pain Medicine
Bochum, Germany
Sponsors and Collaborators
Ruhr University of Bochum
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr., Prof. Dr., Ruhr University of Bochum Identifier: NCT01540890     History of Changes
Other Study ID Numbers: Polysom2012
Study First Received: February 23, 2012
Last Updated: March 17, 2014
Health Authority: Germany: Ethics Commission processed this record on November 30, 2015