Opiate Sleep Disordered Breathing Study

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ClinicalTrials.gov Identifier: NCT00791674

Recruitment Status : Unknown

Verified November 2008 by Adelaide Institute for Sleep Health.
Recruitment status was: Recruiting

First Posted : November 14, 2008

Last Update Posted : November 14, 2008

Sponsor:

Collaborator:

Flinders Medical Centre

Information provided by:

Adelaide Institute for Sleep Health

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
Sleep Apnea

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

To define the prevalence of sleep disordered breathing in a group of patients on oral morphine for chronic pain.
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
Estimated 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 :	December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
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 (

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	Dr.Anand Rose, Adelaide Institute of Sleep Health
ClinicalTrials.gov Identifier:	NCT00791674 History of Changes
Other Study ID Numbers:	50/07
First Posted:	November 14, 2008 Key Record Dates
Last Update Posted:	November 14, 2008
Last Verified:	November 2008

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 Wake Disorders Nervous System Diseases	Opiate Alkaloids Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents

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