Opiate Sleep Disordered Breathing Study

NCT ID: NCT00791674

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Apnea

Keywords

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Opiates sleep apnea ventilatory failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flinders Medical Centre

OTHER_GOV

Sponsor Role collaborator

Adelaide Institute for Sleep Health

OTHER

Sponsor Role lead

Responsible Party

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Adelaide Institute of Sleep Health

Principal Investigators

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Anand R Rose, MD,FRACP

Role: PRINCIPAL_INVESTIGATOR

Adelaide Institute of Sleep Health

Doug McEvoy, MD, FRACP

Role: STUDY_DIRECTOR

Adelaide Institute of Sleep Health, Repatriation General Hospital

Locations

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Pain Management Unit, Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status RECRUITING

Adelaide Institute of Sleep Health, Repatriation General Hospital,

Daw Park, South Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Anand R Rose, MD, FRACP

Role: CONTACT

Phone: 61882769666

Email: [email protected]

Denzil Paul, M Biotech

Role: CONTACT

Phone: 61882769666

Email: [email protected]

Facility Contacts

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Dilip Kapur, FRCA, FANZCA

Role: primary

Anand R Rose, MD,FRACP

Role: primary

Other Identifiers

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50/07

Identifier Type: -

Identifier Source: org_study_id