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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01540890

Enrollment

Registered

2012-02-29

Start date

2011-11-30

Completion date

2013-02-28

Last updated

2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Architecture Under Opioid Medication

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
frequency of an abnormal apnoea-hypnoea index	3 weeks

Secondary

Measure	Time frame
changes of the sleep duration and architecture	3 weeks

Countries

Germany

Outcome results