Opiate Sleep Disordered Breathing Study

November 13, 2008 updated by: Adelaide Institute for Sleep Health

Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy

Lay title: A study of breathing pauses during sleep in patients on long term opiates.

Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals from the brain driving breathing (central sleep apnoea). Clinical observation has noticed that patients on opiates have an increase in sleep apnoea.

Hypothesis: This study looks at the relationship of opiates (when used for patients chronic pain) and the occurrence of sleep apnoea. It is expected that there will be an increase in sleep apnoea (particularly of the central variant) particularly in patients on long term opiates.

Study Overview

Status

Unknown

Conditions

Detailed Description

The purpose for this study is to test the hypothesis that sleep disordered breathing is more prevalent amongst a group of patients on high dose opiates for chronic pain.

Aims

  1. To define the prevalence of sleep disordered breathing in a group of patients on oral morphine for chronic pain.
  2. To determine the prevalence of respiratory failure in this cohort of patients. Patients on long term opiates (>6 months) from an outpatient pain clinic population on long acting morphine formulations > 40 mg/day, Oxycontin 30 mg/day, and Methadone > 20 mg/day were prospectively recruited. Home polysomnograms were done on them. During their clinical review they have spirometry, arterial blood gases, psychomotor vigilance tests done on them.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Pain Management Unit, Flinders Medical Centre
        • Contact:
        • Sub-Investigator:
          • John Plummer, PhD, AStat
      • Daw Park, South Australia, Australia, 5041
        • Recruiting
        • Adelaide Institute of Sleep Health, Repatriation General Hospital,
        • Contact:
          • Anand R Rose, MD,FRACP
        • Sub-Investigator:
          • Nick Antic, PhD, FRACP
        • Sub-Investigator:
          • Doug McEvoy, MD, FRACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pain clinic outpatients were contacted if they were on the specified doses (

Description

Inclusion Criteria:

  • Patients on long acting Morphine >40mg/day, Oxycontin >30mg/day, and Methadone >20mg/day were contacted.
  • Stable opiate dose for 2 weeks
  • Lives within 80KM of FMC

Exclusion Criteria:

  • Significant CCF/CVA
  • Severe COPD
  • Major Psychiatric illness
  • History of substance abuse in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of sleep disordered breathing in patients on long term opiates.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of ventilatory failure in this cohort
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adelaide Institute for Sleep Health

Collaborators

Flinders Medical Centre

Investigators

  • Principal Investigator: Anand R Rose, MD,FRACP, Adelaide Institute of Sleep Health
  • Study Director: Doug McEvoy, MD, FRACP, Adelaide Institute of Sleep Health, Repatriation General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Estimate)

November 14, 2008

Last Update Submitted That Met QC Criteria

November 13, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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