Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000858594
Ethics application status
Approved
Date submitted
9/07/2015
Date registered
18/08/2015
Date last updated
25/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Cooperative Research Centre (CRC) for Alertness, Safety and Productivity: Respiratory Phenotyping for Obstructive Sleep Apnea - Oxygen therapy in combination with Zopiclone
Scientific title
Oxygen therapy in combination with Zopiclone administration to treat obstructive sleep apnoea in patients with unstable respiratory control who partially respond to oxygen treatment.
Secondary ID [1] 286012 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 293975 0
Condition category
Condition code
Respiratory 294275 294275 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Descriptions of intervention(s) / exposure: Interventions: Zopiclone and oxygen

This is a pilot study of combination treatment with Zopiclone and oxygen so both will be administered on the same night.

Zopiclone
a) Dose administered: 7.5 mg
b) Duration of administration: single administration, just prior to bedtime, during the overnight laboratory study visit for polysomnography.
c) Mode of administration: oral tablet
d) Details of study visits required: single overnight laboratory study visit for polysomnography.
e) Strategy to monitor adherence: oral ingestion of tablet to be witnessed by research staff.

Oxygen
a) Dose administered: 4L/min
b) Duration of administration: throughout a single overnight laboratory study visit for polysomnography, from just prior to bedtime to final wake up time.
c) Mode of administration: delivered by nasal cannula
d) Details of study visits required: single overnight laboratory study visit for polysomnography.
e) Strategy to monitor adherence: Research staff monitoring of cannula placement and flow rate

Outcomes will be compared to a baseline (diagnostic) sleep study, which is collected as part of standard clinical practice for the diagnosis of Obstructive Sleep Apnoea (see inclusion criteria). Comparisons will also be made to separate air and O2 study nights collected as part of the main study (ACTRN12615000918527). Baseline (diagnostic) sleep studies will be conducted from April 2015 – December 2017.

The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).
Intervention code [1] 290993 0
Treatment: Drugs
Intervention code [2] 290994 0
Treatment: Devices
Comparator / control treatment
This is an uncontrolled pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294074 0
Apnoea-Hypopnoea Index (AHI) scored without conventional oxygen desaturation criteria and compared to baseline (diagnostic) sleep study scored with the same criteria.
Timepoint [1] 294074 0
AHI assessed without standard desaturation criteria will be measured from each overnight polysomnography study already conducted in preceding trials (baseline night, single night of O2 treatment alone, single night of air (control) treatment) compared to this trial intervention (single night of oxygen plus zopiclone). The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).
Secondary outcome [1] 312476 0
Conventionally scored (including normal desaturation criteria) AHI compared to the baseline (diagnostic) sleep study
Timepoint [1] 312476 0
AHI indices will be measured from each overnight polysomnography study already conducted in preceding trials (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared to this trial intervention (single night of oxygen plus zopiclone).
Secondary outcome [2] 315880 0
Oxygen desaturation measured from overnight polysomnography study
Timepoint [2] 315880 0
Oxygen desaturation indices will be measured from each overnight polysomnography study already conducted in preceding trials (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared to this trial intervention (single night of oxygen plus zopiclone).
Secondary outcome [3] 315881 0
Minimum oxygen saturation measured from overnight polysomnography study
Timepoint [3] 315881 0
Minimum oxygen saturation will be measured from each overnight polysomnography study already conducted in preceding trials (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared to this trial intervention (single night of oxygen plus zopiclone).
Secondary outcome [4] 315882 0
Respiratory event duration measured from overnight polysomnography study
Timepoint [4] 315882 0
Respiratory event duration will be measured from each overnight polysomnography study already conducted in preceding trials (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared to this trial intervention (single night of oxygen plus zopiclone).
Secondary outcome [5] 315883 0
Arousal frequency measured from overnight polysomnography study
Timepoint [5] 315883 0
Arousal frequency will be measured from each overnight polysomnography study already conducted in preceding trials (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared to this trial intervention (single night of oxygen plus zopiclone).

Eligibility
Key inclusion criteria
- Diagnosed with obstructive sleep apnoea (OSA)
- Demonstrated partial treatment response to one night of oxygen therapy (defined as AHI being reduced by 50% or more on oxygen versus air, but AHI on oxygen still greater than or equal to 10/hour), as part of the study CRC Respiratory Phenotyping for Obstructive Sleep Apnea.

The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A history of significant COPD (gold criteria 3-4), chronic ventilatory failure from any other cause or psychiatric disorders likely to place the patient at a higher than normal risk or likely to confound experimental treatment outcomes.
- Age >65 years
- Pregnancy or nursing mother
- Any major contra-indication for Zopiclone (known hypersensitivity to Zopiclone or any of the excipients, prior or concomitant use of alcohol, myasthenia gravis, severe impairments of hepatic function and acute cerebrovascular accident).
- Physician recommended exclusion
- Patient unable (i.e. language difficulties) or unwilling to consent
- Central sleep apnoea (central apnea index >5 /hr)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 290611 0
Other Collaborative groups
Name [1] 290611 0
Cooperative Research Centre (CRC) for Alertness, Safety and Productivity
Country [1] 290611 0
Australia
Primary sponsor type
Individual
Name
A/Prof Peter Catcheside
Address
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Rd
Daw Park, 5041
South Australia
Country
Australia
Secondary sponsor category [1] 290291 0
None
Name [1] 290291 0
Address [1] 290291 0
Country [1] 290291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292241 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 292241 0
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Ethics committee country [1] 292241 0
Australia
Date submitted for ethics approval [1] 292241 0
24/11/2014
Approval date [1] 292241 0
04/03/2015
Ethics approval number [1] 292241 0
21.15 - HREC/15/SAC/13

Summary
Brief summary
Brief summary: Current clinical management of OSA is to use continuous positive airway pressure (CPAP) as a first-line treatment. However, patient tolerance and compliance with CPAP is an ongoing problem in sleep medicine. This study recognizes that alternative treatments better targeted to underlying causal deficits may lead to improved treatment outcomes for patients. Oxygen therapy combined with a sedative (Zopiclone) is one form of combination treatment that could potentially treat a sub-group of OSA patients who have unstable breathing and heightened awakening responses underpinning their OSA.

The aim of this study is to investigate if oxygen combined with a commonly used sedative, Zopiclone, could be used to effectively treatment OSA in some patients. Participants will be recruited from the study “CRC Respiratory Phenotyping for Obstructive Sleep Apnea”.

The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54242 0
A/Prof Peter Catcheside
Address 54242 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Rd
Daw Park, 5041
South Australia
Country 54242 0
Australia
Phone 54242 0
+ 61 8 8275 1187
Fax 54242 0
Email 54242 0
peter.catcheside@flinders.edu.au
Contact person for public queries
Name 54243 0
A/Prof Peter Catcheside
Address 54243 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Rd
Daw Park, 5041
South Australia
Country 54243 0
Australia
Phone 54243 0
+ 61 8 8275 1187
Fax 54243 0
Email 54243 0
peter.catcheside@flinders.edu.au
Contact person for scientific queries
Name 54244 0
A/Prof Peter Catcheside
Address 54244 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Rd
Daw Park, 5041
South Australia
Country 54244 0
Australia
Phone 54244 0
+ 61 8 8275 1187
Fax 54244 0
Email 54244 0
peter.catcheside@flinders.edu.au

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

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