Opiate Sleep Disordered Breathing Study

Sleep Apnea Clinical Trial

Official title:

Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00791674
• Other study ID #: 50/07
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2008
• Last updated: November 13, 2008
• Start date: December 2007

Study information

• Verified date: November 2008
• Source: Adelaide Institute for Sleep Health
• Contact: Anand R Rose, MD, FRACP
• Phone: 61882769666
• Email: anand.rose[@]health.sa.gov.au
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep Apnea

Locations

Country	Name	City	State
Australia	Pain Management Unit, Flinders Medical Centre	Bedford Park	South Australia
Australia	Adelaide Institute of Sleep Health, Repatriation General Hospital,	Daw Park	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Adelaide Institute for Sleep Health	Flinders Medical Centre

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of sleep disordered breathing in patients on long term opiates.		18 months	No
Secondary	Prevalence of ventilatory failure in this cohort		18 months	No