Clinical trial NCT00791674: Opiate Sleep Disordered Breathing Study
Official title: Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Keywords: Opiates
sleep apnea
ventilatory failure
Lead sponsor: Adelaide Institute for Sleep Health
Sponsor class: OTHER
Collaborators: name: Flinders Medical Centre
First posted: 2008-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pain clinic outpatients were contacted if they were on the specified doses (

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.

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

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of sleep disordered breathing in patients on long term opiates.
timeFrame: 18 months
Secondary outcomes:
measure: Prevalence of ventilatory failure in this cohort
timeFrame: 18 months
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Pain Management Unit, Flinders Medical Centre
state: South Australia
city: Daw Park
country: Australia
facility: Adelaide Institute of Sleep Health, Repatriation General Hospital,
state: South Australia
Study officials:
affiliation: Adelaide Institute of Sleep Health
name: Anand R Rose, MD,FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Adelaide Institute of Sleep Health, Repatriation General Hospital
name: Doug McEvoy, MD, FRACP
role: STUDY_DIRECTOR
References: