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

NCT ID: NCT01540890

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Architecture Under Opioid Medication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

withdrawal

patients who undergo an opioid withdrawal

No interventions assigned to this group

opioids

patients on opioid medication without withdrawal

No interventions assigned to this group

opioid-free

patients with chronic pain without opioid medication

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christoph Maier, Prof. Dr.

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Pain Medicine

Bochum, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Polysom2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Indoor Temperature and Sleep Apnea
NCT00544752 COMPLETED NA
Sleep Measurement Study
NCT04288557 COMPLETED