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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00791674




Registration number
NCT00791674
Ethics application status
Date submitted
13/11/2008
Date registered
14/11/2008
Date last updated
14/11/2008

Titles & IDs
Public title
Opiate Sleep Disordered Breathing Study
Scientific title
Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy
Secondary ID [1] 0 0
50/07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of sleep disordered breathing in patients on long term opiates.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Prevalence of ventilatory failure in this cohort
Timepoint [1] 0 0
18 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant CCF/CVA

- Severe COPD

- Major Psychiatric illness

- History of substance abuse in the last 3 months

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Pain Management Unit, Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Adelaide Institute of Sleep Health, Repatriation General Hospital, - Daw Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
5041 - Daw Park

Funding & Sponsors
Primary sponsor type
Other
Name
Adelaide Institute for Sleep Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders Medical Centre
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00791674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anand R Rose, MD,FRACP
Address 0 0
Adelaide Institute of Sleep Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anand R Rose, MD, FRACP
Address 0 0
Country 0 0
Phone 0 0
61882769666
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00791674