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Impairement of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparisson to Patients Without Opioid Withdrawal

This study is currently recruiting participants.
Verified February 2012 by Ruhr University of Bochum
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01540890
First received: February 23, 2012
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  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 apnoe-hypnoe 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 ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: September 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 opiod 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540890

Contacts
Contact: Christoph Maier 0049-234-302-6366 christoph.maier@rub.de

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

No publications provided

Responsible Party: Christoph Maier, 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: February 28, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013