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Opiate Sleep Disordered Breathing Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Adelaide Institute for Sleep Health.
Recruitment status was:  Recruiting
Flinders Medical Centre
Information provided by:
Adelaide Institute for Sleep Health Identifier:
First received: November 13, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

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.

Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy

Resource links provided by NLM:

Further study details as provided by Adelaide Institute for Sleep Health:

Primary Outcome Measures:
  • Prevalence of sleep disordered breathing in patients on long term opiates. [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Prevalence of ventilatory failure in this cohort [ Time Frame: 18 months ]

Estimated Enrollment: 50
Study Start Date: December 2007
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.


  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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pain clinic outpatients were contacted if they were on the specified doses (

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
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Please refer to this study by its identifier: NCT00791674

Contact: Anand R Rose, MD, FRACP 61882769666 ext 247
Contact: Denzil Paul, M Biotech 61882769666

Australia, South Australia
Pain Management Unit, Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Dilip Kapur, FRCA, FANZCA    61882045511   
Sub-Investigator: John Plummer, PhD, AStat         
Adelaide Institute of Sleep Health, Repatriation General Hospital, Recruiting
Daw Park, South Australia, Australia, 5041
Contact: Anand R Rose, MD,FRACP         
Sub-Investigator: Nick Antic, PhD, FRACP         
Sub-Investigator: Doug McEvoy, MD, FRACP         
Sponsors and Collaborators
Adelaide Institute for Sleep Health
Flinders Medical Centre
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
  More Information

Responsible Party: Dr.Anand Rose, Adelaide Institute of Sleep Health Identifier: NCT00791674     History of Changes
Other Study ID Numbers: 50/07
Study First Received: November 13, 2008
Last Updated: November 13, 2008

Keywords provided by Adelaide Institute for Sleep Health:
sleep apnea
ventilatory failure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on June 23, 2017