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Trial registered on ANZCTR


Registration number
ACTRN12608000318381
Ethics application status
Approved
Date submitted
12/06/2008
Date registered
9/07/2008
Date last updated
17/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Double Blind Randomised Crossover Trial of Temazepam in Mild to Moderate Obstructive Sleep Apnea
Scientific title
Efficacy of Teazepam in reducing Apnea Hypopnea Index as measured by standard overnight polysomnography in mild to moderate obstructive sleep apnea.
Secondary ID [1] 253424 0
SSWAHS Ethics Review Committee (Protocol No: X08-0079)
Universal Trial Number (UTN)
Trial acronym
TEMOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea (OSA) 3258 0
Condition category
Condition code
Respiratory 3423 3423 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 mg Temazepam over 1 night only administered orally. As this is a crossover study, there will be a 2 week washout period.
Intervention code [1] 3000 0
Treatment: Drugs
Comparator / control treatment
Placebo (sugar pill).
Administered orally over 1 night only
Control group
Placebo

Outcomes
Primary outcome [1] 4318 0
Apnea Hypopnea Index (AHI)
Timepoint [1] 4318 0
Measured by standard overnight polysomnography (PSG) for both nights (i.e. the night temazepam is administered and the night placebo is administered.)
Secondary outcome [1] 7280 0
Correlation between reduced AHI and hypoxic ventilatory response (HVR) and hypercapnic ventilatory response (HVCR).
Timepoint [1] 7280 0
Ventilatory responses taken at all 3 visits (baseline, study medication visit, and placebo visit.)

Eligibility
Key inclusion criteria
Patients must be male, aged 18 to 70, Body Mass Index (BMI) < 35, diagnosed obstructive sleep apnea by overnight polysomnography (Apnea-Hypopnea Index =5, = 30), and refuse or cannot tolerate a continuous positive airway pressure device and/or a mandibular advancement splint.
Minimum age
18 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are suffering from any uncontrolled concurrent medical or psychiatric illness, if they are currently taking any medications that are known to affect sleep or that may cause a drug interaction with Temazepam, if they have medical conditions that would contraindicate administration of Temazepam or if they have irregular sleep patterns, such as shift-workers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After written consent, patients will be enrolled in a randomised order placebo-controlled crossover double blind study. After the baseline visit patients will be randomly assigned, by equal chance, either 10mg Temazepam or placebo. Allocation is concealed via central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3481 0
Charities/Societies/Foundations
Name [1] 3481 0
Woolcock Institute of Medical Research
Address [1] 3481 0
431 Glebe Point Road
GLEBE NSW 2037
Country [1] 3481 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road
GLEBE NSW 2037
Country
Australia
Secondary sponsor category [1] 3123 0
None
Name [1] 3123 0
Address [1] 3123 0
Country [1] 3123 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5511 0
Sydney South West Area Health Services (SSWAHS) Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 5511 0
c/- Research Development Office
Level 8, Building 14
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 5511 0
Australia
Date submitted for ethics approval [1] 5511 0
Approval date [1] 5511 0
27/05/2008
Ethics approval number [1] 5511 0
08/RPAH/130

Summary
Brief summary
The efficacy of Temazepam on sleep disordered breathing in untreated patients with mild to moderate OSA as measured by the Apnea Hypopnea Index (AHI) via standard overnight polysomnography (PSG). The effect of temazepam on OSA will be correlated with awake HVR and HCVR. The hypothesis is that Temazepam reduction of OSA will be correlated with the baseline HVR and HCVR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28666 0
Address 28666 0
Country 28666 0
Phone 28666 0
Fax 28666 0
Email 28666 0
Contact person for public queries
Name 11823 0
Ms. Nargis Noori
Address 11823 0
Woolcock Institute of Medical Research,PO Box M77, Missenden Rd, Camperdown, NSW, 2050
Country 11823 0
Australia
Phone 11823 0
+61 2 9114 0498
Fax 11823 0
+61 2 9114 0014
Email 11823 0
nnoo3880@mail.usyd.edu.au
Contact person for scientific queries
Name 2751 0
Professor Ron Grunstein
Address 2751 0
Woolcock Institute of Medical Research,PO Box M77, Missenden Rd, Camperdown, NSW, 2050
Country 2751 0
Australia
Phone 2751 0
+61 2 9515 8630
Fax 2751 0
+61 2 9114 0014
Email 2751 0
swilliams@woolcock.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary