Opiate Sleep Disordered Breathing Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Adelaide Institute for Sleep Health.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Flinders Medical Centre
Information provided by:
Adelaide Institute for Sleep Health
ClinicalTrials.gov Identifier:
NCT00791674
First received: November 13, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of ventilatory failure in this cohort [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791674

Contacts
Contact: Anand R Rose, MD, FRACP 61882769666 ext 247 anand.rose@health.sa.gov.au
Contact: Denzil Paul, M Biotech 61882769666 denzil.paul@health.sa.gov.au

Locations
Australia, South Australia
Pain Management Unit, Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Dilip Kapur, FRCA, FANZCA    61882045511    dilip.kapur@health.sa.gov.au   
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
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
  More Information

No publications provided

Responsible Party: Dr.Anand Rose, Adelaide Institute of Sleep Health
ClinicalTrials.gov Identifier: NCT00791674     History of Changes
Other Study ID Numbers: 50/07
Study First Received: November 13, 2008
Last Updated: November 13, 2008
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014