NCT00791674

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
Last Updated

November 14, 2008

Status Verified

November 1, 2008

First QC Date

November 13, 2008

Last Update Submit

November 13, 2008

Conditions

Sleep Apnea

Keywords

Opiatessleep apneaventilatory failure

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sleep disordered breathing in patients on long term opiates.

    18 months

Secondary Outcomes (1)

  • Prevalence of ventilatory failure in this cohort

    18 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Significant CCF/CVA
  • Severe COPD
  • Major Psychiatric illness
  • History of substance abuse in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pain Management Unit, Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Adelaide Institute of Sleep Health, Repatriation General Hospital,

Daw Park, South Australia, 5041, Australia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesHypoventilation

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory InsufficiencySigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anand R Rose, MD,FRACP

    Adelaide Institute of Sleep Health

    PRINCIPAL INVESTIGATOR

  • Doug McEvoy, MD, FRACP

    Adelaide Institute of Sleep Health, Repatriation General Hospital

    STUDY DIRECTOR

Central Study Contacts

Anand R Rose, MD, FRACP

CONTACT

61882769666anand.rose@health.sa.gov.au

Denzil Paul, M Biotech

CONTACT

61882769666denzil.paul@health.sa.gov.au

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

December 1, 2007

Last Updated

November 14, 2008

Record last verified: 2008-11

Locations

AU(2)