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Trial registered on ANZCTR


Registration number
ACTRN12612001004853
Ethics application status
Approved
Date submitted
17/09/2012
Date registered
18/09/2012
Date last updated
9/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of common sleeping pills on arousal and muscle function during sleep
Scientific title
Effects of common sedatives on respiratory arousal and upper airway muscle function during sleep in healthy men and women with and without sleep apnoea
Secondary ID [1] 281240 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep apnoea 287432 0
Condition category
Condition code
Respiratory 287767 287767 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: temazepam (10mg), once only immediately before going to bed, taken orally
Arm 2 zopiclone (7.5mg), once only immediately before going to bed, taken orally
Arm 3: zolpidem (10mg), once only immediately before going to bed, taken orally
1 week washout between treatments
Intervention code [1] 285707 0
Treatment: Drugs
Comparator / control treatment
Placebo, taken orally (participants will act as thier own controls in a cross-over design)
Control group
Placebo

Outcomes
Primary outcome [1] 287996 0
Respiratory arousal threshold (negative pharyngeal pressure immediately prior to arousal from sleep using an epiglottic pressure catheter inserted via the nostril)
Timepoint [1] 287996 0
Acute overnight studies on drug vs. placebo
Secondary outcome [1] 299227 0
Upper airway muscle responsiveness (EMG)
Timepoint [1] 299227 0
Acute overnight studies on drug vs. placebo
Secondary outcome [2] 299228 0
Upper airway collapsibility (Pcrit)
Timepoint [2] 299228 0
Acute overnight studies on drug vs. placebo
Secondary outcome [3] 299229 0
Respiratory control stability (loop gain)
Timepoint [3] 299229 0
Acute overnight studies on drug vs. placebo
Secondary outcome [4] 299230 0
Ventilatory responses
Timepoint [4] 299230 0
Acute overnight studies on drug vs. placebo

Eligibility
Key inclusion criteria
Healthy men and women with and without sleep apnoea
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Known allergy or previous adverse reaction to temazepam, zopiclone or zolpidem
-Medications known to affect muscle activity or sleep
-Pregnant or nursing mothers

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
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)
NSW

Funding & Sponsors
Funding source category [1] 286018 0
University
Name [1] 286018 0
University of New South Wales
Address [1] 286018 0
UNSW Medicine
University of New South Wales
SYDNEY NSW 2052
Country [1] 286018 0
Australia
Funding source category [2] 287829 0
Government body
Name [2] 287829 0
NHMRC (APP1042493)
Address [2] 287829 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [2] 287829 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 284834 0
None
Name [1] 284834 0
Address [1] 284834 0
Country [1] 284834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288069 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 288069 0
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 288069 0
Australia
Date submitted for ethics approval [1] 288069 0
Approval date [1] 288069 0
14/03/2012
Ethics approval number [1] 288069 0
HC12028

Summary
Brief summary
The purpose of this physiology study is to examine the effects of common sleeping pills (sedatives) on the awakening (arousal) response to respiratory stimuli during sleep and their effects on upper airway muscles, airway function, and breathing responses during sleep.
Trial website
Nil
Trial related presentations / publications
Carberry JC, Fisher LP, Grunstein RR, Gandevia SC, McKenzie DK, Butler JE, Eckert DJ. Role of common hypnotics on the phenotypic causes of OSA: Paradoxical effects of zolpidem. Eur Respir J 2017;50:pii: 1701344 doi:10.1183/13993003.01344-2017.
Public notes
Nil

Contacts
Principal investigator
Name 34718 0
Dr Danny Eckert
Address 34718 0
Neuroscience Research Australia Barker Street Randwick, NSW 2031
Country 34718 0
Australia
Phone 34718 0
+61 2 9399 1814
Fax 34718 0
Email 34718 0
d.eckert@neura.edu.au
Contact person for public queries
Name 17965 0
Dr Dr. Danny Eckert
Address 17965 0
Neuroscience Research Australia
Barker Street
Randwick, NSW
2031
Country 17965 0
Australia
Phone 17965 0
+61 2 9399 1814
Fax 17965 0
Email 17965 0
d.eckert@neura.edu.au
Contact person for scientific queries
Name 8893 0
Dr Dr. Danny Eckert
Address 8893 0
Neuroscience Research Australia
Barker Street
Randwick, NSW
2031
Country 8893 0
Australia
Phone 8893 0
+61 2 9399 1814
Fax 8893 0
Email 8893 0
d.eckert@neura.edu.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