Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000392561
Ethics application status
Approved
Date submitted
31/08/2006
Date registered
5/09/2006
Date last updated
21/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Opioid and ventilatory control during sleep
Scientific title
Effect of morphine on arousal and ventilatory responses to hypoxia and hypercapnia during sleep on healthy men
Secondary ID [1] 283425 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers 1358 0
Condition category
Condition code
Blood 1450 1450 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We planned to test 11 healthy men on 4 randomly assigned nights including two active nights and two control nights. There will be at least one week interval between any two nights. Overnight polysomnography will be recorded for all the 4 nights. In the two active nights, 30mg controlled-release oral morphine (MS Contin) will be given to each subject 4 hours before sleep. Upper airway resistance will be measured prior to the first active night sleep and prior to the matching control night sleep. Arousal and ventilatory response tests are not performed during the sleep of the first active night nor on the matching control night. During the second active night and its matching control night, arousal and ventilatory responses to hypoxia and hypercapnia during stage 2 sleep (stable sleep) would be tested.
Intervention code [1] 1341 0
Treatment: Drugs
Comparator / control treatment
Two control nights
Control group
Active

Outcomes
Primary outcome [1] 2000 0
Arousal and ventilatory responses to hypoxia and hypercapnia during sleep
Timepoint [1] 2000 0
The responses would be tested during the second active night and its matching control night. During the 2 nights, the responses would be tested once for hypoxia and once for hypercapnia during stage 2 sleep (stable sleep).
Secondary outcome [1] 3467 0
Sleep-disordered breathing and Upper airway resistance
Timepoint [1] 3467 0
Upper airway resistance would be tested just before bed time on the first active night and its matching control night.
Secondary outcome [2] 3468 0
Sleep-disordered breathing would be tested continuously throughout that two nights.
Timepoint [2] 3468 0
Monitored continuously throughout the 2 study nights

Eligibility
Key inclusion criteria
BMI<30 kg/m2.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of drug abuse. 2. History of symptomatic or known sleep apnea, heavy snoring, shift work sleep disorder or other sleep disorder. 3. Chronic insomnia and/or chronic pain for more than 6 months. 4. History of severe physiological or psychological illness. 5. Subjects with current physical complaints (such as flu or rhinitis) will not be included until symptoms are clear for a week.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
11
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1587 0
Other
Name [1] 1587 0
Woolcock Institute of Medical Research
Country [1] 1587 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Rd, Glebe, NSW 2037
Country
Australia
Secondary sponsor category [1] 1394 0
None
Name [1] 1394 0
Nil
Address [1] 1394 0
Country [1] 1394 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290066 0
SSWAHS Ethics Review Committee
Ethics committee address [1] 290066 0
Level 8, Building 14, RPAH, Camperdown, 2050, NSW
Ethics committee country [1] 290066 0
Australia
Date submitted for ethics approval [1] 290066 0
Approval date [1] 290066 0
13/11/2006
Ethics approval number [1] 290066 0
x06 0217

Summary
Brief summary
Opioids are commonly used for acute and chronic pain management and as an adjunct to anaesthesia. Prescribed opioid-related deaths account for most of non-illicit drug poisoning deaths in America. Death from opioids is nearly always due to respiratory arrest. However, no study has assessed opioid effects on neural-chemical control of breathing during sleep, when respiratory drives are already naturally blunted and protective voluntary breathing is not possible. The present study may meet this gap in knowledge. In addition, this study may reveal whether the potential abnormalities in neural-chemical drive may progress to sleep-disordered breathing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27948 0
Dr Dr David Wang
Address 27948 0
Centre for Respiratory Failure and Sleep Disorders, Level E11 Royal Prince Alfred Hospital Missenden Rd Camperdown NSW 2050
Country 27948 0
Australia
Phone 27948 0
+61 2 91140446
Fax 27948 0
Email 27948 0
[email protected]
Contact person for public queries
Name 10530 0
Dr Sarah Newton-John
Address 10530 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10530 0
Australia
Phone 10530 0
+61 2 95156578
Fax 10530 0
+61 2 95505865
Email 10530 0
[email protected]
Contact person for scientific queries
Name 1458 0
Dr David Wang
Address 1458 0
Centre for Respiratory Failure and Sleep Disorders
Level E11
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 1458 0
Australia
Phone 1458 0
+61 2 95155048
Fax 1458 0
+61 2 95157196
Email 1458 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.