Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001038381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/04/2026
Date registered
Help: Date registered
24/08/2026
Date last updated
Help: Date last updated
24/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of intensive telemonitoring on Continuous Positive Airways Pressure (CPAP) adherence
Scientific title
A prospective non-randomized control trial comparing CPAP acclimatisation and continuing treatment with intensive telemonitoring, as compared to acclimatization and continuing treatment with usual care at Australian Capital Territory (ACT)
Additional trial identifiers [1] 317058 0
2025.LRE.00018
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Obstructive sleep apnea 341576 0
Condition category
Condition code
Respiratory 337645 337645 0 0
Sleep apnoea
Public Health 337740 337740 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
All patients will undergo CPAP acclimatisation delivered through Air Liquide Healthcare (ALH), but those in the telemonitoring arm will also have daily telemonitoring reviews in addition to ALH’s usual acclimatisation protocol. Once successfully acclimatized and compliant with a usage of equal or greater from 4hrs a night for a minimum of 70% of nights over a 4-week period, participants will then go on to either continue with intensive telemonitoring for the remainder of the year in addition to seeing their sleep physician, or will go back to their sleep physician to receive usual care.

Both arms Participants arm use a commercial Philips DreamStation AutoCPAP machine nightly during sleep to treat OSA. As for the intensive telemonitoring arm, telemonitoring involves staff daily reviewing data (adherence, leak, and efficacy) with a customer service team (specifically addressed as "care team") who reach out patients essentially through phone calls (SMS when not available) to support the patient. When the care team is unable to solve the issue remotely through phone calls, the patient may be referred back to the CPAP consultants at the CPAP clinic, prior to escalation to the referring Prescriber. All interactions with the patients are tracked in 'minutes' as to integrate the cost of care in the review of the value based healthcare approach.

Here below are the therapy data criteria leading to intervention by the care team:
1- Excessive mask leak: over 24 L per min on two consecutive days.
2- Low therapy usage: Average daily usage falls below 4-hours over seven consecutive days.
3- Inadequate treatment efficacy: An Apnea-Hypopnea Index or AHI over 8 events per hour on two consecutive days.
4- No usage: Zero recorded usage on two consecutive days.
5- Data transmission issues: No data transmitted from the device on two consecutive days.
Intervention code [1] 333814 0
Treatment: Devices
Intervention code [2] 333864 0
Behaviour
Description of the comparator or control
Usual Care: Participants receive standard CPAP acclimatisation per Air Liquide Healthcare (ALH) protocol and are then referred back to their physician for standard follow-up when required. No telemonitoring.
Control group
Active

Outcomes
Primary outcome [1] 345131 0
The proportion of patients who are adherent to CPAP (defined as usage of minmum of 4hrs for at least 70% of days over 4 weeks) at 12 months.
Timepoint [1] 345131 0
12 month (365 day) from therapy initiation.
Primary outcome [2] 345195 0
% of patients adherent to CPAP therapy at 3 months and 6 months
Timepoint [2] 345195 0
3 and 6 months from therapy initiation (day 1).
Secondary outcome [1] 460577 0
CPAP therapy average daily usage, in hours : minutes
Timepoint [1] 460577 0
at 3 months, 6 months and 12 months, from the date of therapy initiation
Secondary outcome [2] 460863 0
Patient's well being status
Timepoint [2] 460863 0
therapy initiation (day-1), day-30, 3, 6, and 12 months from therapy initiation.
Secondary outcome [3] 460864 0
Patient's CPAP Therapy Experience
Timepoint [3] 460864 0
therapy intiation (day-1), day-30, 3, 6, and 12 months post-enrolment
Secondary outcome [4] 461212 0
CPAP therapy attrition rate
Timepoint [4] 461212 0
3, 6 and 12 months from therapy initiation.
Secondary outcome [5] 461218 0
Sleep-related functional status
Timepoint [5] 461218 0
therapy intiation (day-1), day-30, 3, 6, and 12 months post-enrolment
Secondary outcome [6] 465050 0
cost-benefit analysis of the telemonitoring intervention compared to usual care
Timepoint [6] 465050 0
At 12-months from therapy initiation.

Eligibility
Key inclusion criteria
I. CPAP-naïve participants

II. over 16 years of age.

III. Severe OSA (AHI equal or greater to 30).
or
Moderate OSA (AHI equal or greater to 15) and presenting one of the following six symptoms:
1-Excessive Day time sleepiness with ESS equal or greater to 10;
2-Regular loud snoring;
3-Waking choking / gasping;
4-Regular complains of dry mouth;
5-Complains of fragmented sleep;
6- Regular Morning headaches on waking.

and

IV. OSA diagnosed via level 1 or level 2 polysomnography within one year of enrollment, performed through a certified sleep laboratory.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Patient under 16 years of age;
Significant hypoventilation or central apnoeas on polysomnography;
Previous CPAP use;
Inability to speak or read English;
Terminal illness with a life expectancy of less than one year;
Physical or cognitive contraindications to using CPAP therapy.

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
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Other
Other design features
Interventions are applied depending on patients therapy data. Therefore, it does not follow any sequence.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

The primary outcome, along with many of the continuous secondary outcomes will be analyzed using a 2 tailed t-test to assess for a clinically significant difference between our two groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/08/2025
Date of last participant enrolment
Anticipated
1/03/2027
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
415
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 321649 0
Commercial sector/Industry
Name [1] 321649 0
Air Liquide Healthcare
Country [1] 321649 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Air Liquide Healthcare
Address
Country
Australia
Secondary sponsor category [1] 324470 0
Hospital
Name [1] 324470 0
Canberra Hospital
Address [1] 324470 0
Country [1] 324470 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320177 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 320177 0
Ethics committee country [1] 320177 0
Australia
Date submitted for ethics approval [1] 320177 0
16/01/2025
Approval date [1] 320177 0
29/05/2025
Ethics approval number [1] 320177 0

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

Contacts
Principal investigator
Name 149686 0
Dr Samuel Wells
Address 149686 0
ACT Health / Canberra Hospital and the ALH Canberra Sleep Clinic PO Box 11, Woden, ACT 2606
Country 149686 0
Australia
Phone 149686 0
+61 4 0042 3473
Fax 149686 0
Email 149686 0
[email protected]
Contact person for public queries
Name 149687 0
Samuel Wells
Address 149687 0
ACT Health / Canberra Hospital and the ALH Canberra Sleep Clinic, Building 1, Level 6, Canberra Hospital, PO Box 11, Woden, ACT 2606
Country 149687 0
Australia
Phone 149687 0
+61 4 0042 3473
Fax 149687 0
Email 149687 0
[email protected]
Contact person for scientific queries
Name 149688 0
Samuel Wells
Address 149688 0
ACT Health / Canberra Hospital and the ALH Canberra Sleep Clinic , PO Box 11, Woden, ACT 2606
Country 149688 0
Australia
Phone 149688 0
+61 4 0042 3473
Fax 149688 0
Email 149688 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data scientist and study investigators

Conditions for requesting access:
• Access is restricted to those involved in analysis or authorized investigators; data must be de-identified before transfer

What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
The protocol implies data is ready for "other investigators as needed" once it is de-identified for the statistician.


To:
There is no end date for requests for de-identified IPD.

Where can requests to access individual participant data be made, or data be obtained directly?
• Once all of the data is collected and is ready for analysis, it will be de-identified with patients being assigned an ID code based on initials and date of enrollment. The ID code sheet will be kept on ALH’s secure servers in case there is need to re-identify a patient, otherwise this de- identified data is what will be used in the analysis, this will be sent via secure email to our statistician and other investigators as needed. Throughout the process participant privacy and confidentiality will be respected and upheld.

Contacts by email to access to data:
Andy De Jesus (Sponsor): [email protected]
Dr. Samuel Wells: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.