Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000918527
Ethics application status
Approved
Date submitted
20/07/2015
Date registered
2/09/2015
Date last updated
19/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cooperative Research Centre (CRC) for Alertness, Safety and Productivity: Respiratory Phenotyping for Obstructive Sleep Apnoea – Main study
Scientific title
Detailed analysis of the underlying respiratory causes of Obstructive Sleep Apnoea and assessment of the efficacy of oxygen as a treatment option.
Secondary ID [1] 287102 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 295624 0
Condition category
Condition code
Respiratory 295903 295903 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Step 1: Simple OSA respiratory phenotyping via CPAP drops during CPAP titration (this step aims to recruit a total of 300 participants)

Following diagnosis, screening and consent each patient will undergo a single night modified CPAP titration study. The modified CPAP titration study will be administered by research staff, as part of normal care in the sleep laboratory, in order to establish an appropriate CPAP treatment pressure and establish airflow responses to experimental CPAP pressure drops to zero pressure. The modified CPAP titration study is very similar to a routine CPAP titration study. The only difference being the addition of a calibrated airflow sensor measurements and around 5 very brief drops in pressure of the CPAP machine during the night. The averaged airflow responses to these experimental CPAP pressure drops to zero will be used to categorise participants into one of three groups;

a) “good airway” (average peak inspiratory airflow >50% of baseline preceding pressure drops)
b) “intermediate airway” (30-50%)
c) “poor airway” (<30%)

All “good airway” and “intermediate airway” patients and approximately 1 in 4 of the remaining “poor airway” participants chosen at random will be selected for inclusion in Step 2 and 3 of the protocol.


Step 2: Detailed OSA respiratory phenotyping study (this step aims to recruit a total of 120 participants).

All patients will undergo a 1 night detailed in-laboratory sleep and respiratory physiology study using the method described by Wellman et al. (J Appl Physiol., 114(7), 911-22, 2013). This method uses a combination of systematic gradual and rapid CPAP drops and rapid returns to therapeutic pressure to characterise all of the major known pathophysiological deficits and respiratory phenotypes underlying OSA.

As in step 1, patients will be instrumented for a conventional full diagnostic sleep study and wear a snug fitting CPAP mask fitted with a calibrated pneumotachograph to quantify airflow.

Additional secondary measures in sub-groups of patients will be conducted to characterise wake respiratory control. These secondary measures involve a short period of quiet breathing on room air and then breathing from either room air or a gas with increased carbon dioxide levels using a computer controlled system that characterizes the responsiveness of the main carbon dioxide sensitive reflexes that control breathing. The levels of carbon dioxide are similar to the levels normally breathed out and well below those considered unsafe. These measures are conducted prior to bedtime on the night of the in-laboratory sleep study and will be repeated with and without a background of increased O2 levels to investigate the change in CO2 sensitivity when patients are treated with oxygen.

Step 3: Acute 1 night O2 versus 1 night air study (this step aims to recruit all 120 participants from Step 2).

This step will identify patients who can be effectively treated with O2.

All patients will undergo 2 separate in-laboratory sleep study nights, one on O2 therapy the other on air (control) in random order (via minimisation to help achieve balance in key potential confounders, such as gender, age and BMI, between treatment allocation orders) approximately 1 week apart, with patients and sleep study scorers blinded to treatment allocation.

As in step 1 participants will be instrumented for a conventional full diagnostic sleep study but without a mask. Participants will wear 2 nasal cannulae; one for conventional nasal pressure recordings, the other for delivery of O2 or medical air at 4 l/min.

Each step (1-3) will be conducted approximately 1 week apart.
Intervention code [1] 292345 0
Treatment: Other
Comparator / control treatment
Active. All patients will undergo 2 separate in-laboratory sleep study nights one on O2 therapy the other on air (control) in random order (via minimisation to help achieve balance in key potential confounders, such as gender, age and BMI, between treatment allocation orders) approximately 1 week apart
Control group
Active

Outcomes
Primary outcome [1] 295577 0
Apnoea-Hypopnoea Index (AHI) scored without conventional oxygen desaturation criteria
Timepoint [1] 295577 0
AHI assessed without standard desaturation criteria will be measured from each overnight polysomnography study (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared between nights.
Secondary outcome [1] 315969 0
3% Oxygen desaturation index assessed using pulse oximetry
Timepoint [1] 315969 0
3% Oxygen desaturation index will be measured from each overnight polysomnography study (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared between nights.
Secondary outcome [2] 315970 0
Minimum oxygen saturation assessed using pulse oximetry
Timepoint [2] 315970 0
Minimum oxygen saturation will be measured from each overnight polysomnography study (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared between nights.
Secondary outcome [3] 315971 0
Respiratory event duration assessed using polysomnography
Timepoint [3] 315971 0
Respiratory event duration will be measured from each overnight polysomnography study (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared between nights.
Secondary outcome [4] 315972 0
Arousal frequency assessed using polysomnography
Timepoint [4] 315972 0
Arousal frequency will be measured from each overnight polysomnography study (baseline night, single night of O2 treatment alone, single night of air (control) treatment) and compared between nights.

Eligibility
Key inclusion criteria
- Diagnosis of obstructive sleep apnea
- Recommended usual care with CPAP treatment by their treating physician
Minimum age
18 Years
Maximum age
No limit
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 higher than normal risk or likely to confound experimental treatment outcomes.
- Physician recommended exclusion
- Patient unable (e.g. language difficulties) or unwilling to consent
- Central sleep apnea (central apnea index >5 /hr)

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/04/2015
Actual
9/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 291660 0
Other Collaborative groups
Name [1] 291660 0
Cooperative Research Centre (CRC) for Alertness, Safety, and Productivity
Country [1] 291660 0
Australia
Primary sponsor type
Individual
Name
A/Prof Peter Catcheside
Address
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Road
Daw Park
South Australia, 5041
Country
Australia
Secondary sponsor category [1] 290334 0
None
Name [1] 290334 0
Address [1] 290334 0
Country [1] 290334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293186 0
Southern Adelaide Clinical Human Research Ethics Committee (SACHREC)
Ethics committee address [1] 293186 0
Ethics committee country [1] 293186 0
Australia
Date submitted for ethics approval [1] 293186 0
24/11/2014
Approval date [1] 293186 0
22/01/2015
Ethics approval number [1] 293186 0
491.14 - HREC/14/SAC/516

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58838 0
A/Prof Peter Catcheside
Address 58838 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Road
Daw Park
South Australia, 5041
Country 58838 0
Australia
Phone 58838 0
+61 8 8275 1187
Fax 58838 0
Email 58838 0
[email protected]
Contact person for public queries
Name 58839 0
Peter Catcheside
Address 58839 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Road
Daw Park
South Australia, 5041
Country 58839 0
Australia
Phone 58839 0
+61 8 8275 1187
Fax 58839 0
Email 58839 0
[email protected]
Contact person for scientific queries
Name 58840 0
Peter Catcheside
Address 58840 0
Sleep and Respiratory Medicine
Repatriation General Hospital
Daws Road
Daw Park
South Australia, 5041
Country 58840 0
Australia
Phone 58840 0
+61 8 8275 1187
Fax 58840 0
Email 58840 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
SourceTitleYear of PublicationDOI
Dimensions AIAn assessment of a simple clinical technique to estimate pharyngeal collapsibility in people with obstructive sleep apnea2020https://doi.org/10.1093/sleep/zsaa067
N.B. These documents automatically identified may not have been verified by the study sponsor.