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
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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 |
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Sleep Apnea |
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 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 |
- Prevalence of sleep disordered breathing in patients on long term opiates. [ Time Frame: 18 months ]
- Prevalence of ventilatory failure in this cohort [ Time Frame: 18 months ]

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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 |
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

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
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 |
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 |
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 |
Responsible Party: | Dr.Anand Rose, Adelaide Institute of Sleep Health |
ClinicalTrials.gov Identifier: | NCT00791674 |
Other Study ID Numbers: |
50/07 |
First Posted: | November 14, 2008 Key Record Dates |
Last Update Posted: | November 14, 2008 |
Last Verified: | November 2008 |
Opiates sleep apnea ventilatory failure |
Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |