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OpenTrials
Completed

NCT Number: NCT01540890

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pain Medicine

Bochum, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. frequency of an abnormal apnoea-hypnoea index

    Time frame: 3 weeks

Secondary outcomes

  1. changes of the sleep duration and architecture

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 29, 2012
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.