Opiate Sleep Disordered Breathing Study

Sponsor
Adelaide Institute for Sleep Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT00791674
Collaborator
Flinders Medical Centre (Other)
50
2
25

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy
    Study Start Date :
    Dec 1, 2007

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of sleep disordered breathing in patients on long term opiates. [18 months]

    Secondary Outcome Measures

    1. Prevalence of ventilatory failure in this cohort [18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pain Management Unit, Flinders Medical Centre Bedford Park South Australia Australia 5042
    2 Adelaide Institute of Sleep Health, Repatriation General Hospital, Daw Park South Australia Australia 5041

    Sponsors and Collaborators

    • Adelaide Institute for Sleep Health
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00791674
    Other Study ID Numbers:
    • 50/07
    First Posted:
    Nov 14, 2008
    Last Update Posted:
    Nov 14, 2008
    Last Verified:
    Nov 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2008