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
  Purpose

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.


Condition
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)
Groups/Cohorts
withdrawal
patients who undergo an opioid withdrawal
opioids
patients on opioid medication without withdrawal
opioid-free
patients with chronic pain without opioid medication

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01540890

Locations
Germany
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
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on September 18, 2014