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

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. Identifier: NCT01540890
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : March 18, 2014
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum

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.

Condition or disease
Sleep Architecture Under Opioid Medication

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

patients who undergo an opioid withdrawal
patients on opioid medication without withdrawal
patients with chronic pain without opioid medication

Primary Outcome Measures :
  1. frequency of an abnormal apnoea-hypnoea index [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. changes of the sleep duration and architecture [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540890

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

Responsible Party: Christoph Maier, Prof. Dr., Prof. Dr., Ruhr University of Bochum Identifier: NCT01540890     History of Changes
Other Study ID Numbers: Polysom2012
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents