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
Recruitment status was Recruiting
Sponsor:
Adelaide Institute for Sleep Health
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
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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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00791674
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
| 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 Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on September 27, 2016