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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06769607




Registration number
NCT06769607
Ethics application status
Date submitted
11/11/2024
Date registered
10/01/2025
Date last updated
10/01/2025

Titles & IDs
Public title
Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
Scientific title
Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
Secondary ID [1] 0 0
SLP-24-10-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Investigational algorithm
Treatment: Devices - Control algorithm

Experimental: Investigational algorithm - The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings.

Active comparator: Control algorithm - The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings.


Treatment: Devices: Investigational algorithm
Investigational algorithm developed for the treatment of Obstructive Sleep Apnea.

Treatment: Devices: Control algorithm
Released algorithm intended for the treament of Obstructive Sleep Apnea
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of the algorithm efficacy (AHI) to a clinically relevant data
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Secondary endpoint: Device usage
Timepoint [1] 0 0
From enrolment to the end of each study arm (up to 8 weeks)
Secondary outcome [2] 0 0
Secondary endpoint: Leak
Timepoint [2] 0 0
From enrollment to the end of each study arm (up to 8 weeks)
Secondary outcome [3] 0 0
Secondary endpoint: Pressure
Timepoint [3] 0 0
From enrolment to the end of each study arm (up to 8 weeks)
Secondary outcome [4] 0 0
Secondary endpoint: Subjective scores
Timepoint [4] 0 0
From enrolment to the end of each study arm (up to 8 weeks)

Eligibility
Key inclusion criteria
* Participants willing to give written informed consent.
* Participants who can read and comprehend English.
* Participants who = 18 years of age
* Participants who have been using a ResMed AirSense 10 or 11 device.
* Participants currently using AutoSet (APAP) mode.
* Participants being established on PAP therapy for the treatment of OSA for approximately >3 months.
* Participants who can participate in the study for up to 8 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants using Bilevel flow generators.
* Participants using CPAP, AutoSet for Her
* Participants who are or may be pregnant.
* Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
* Participants believed to be unsuitable for inclusion by the researcher.
* Participants who are currently enrolled in other medical clinical studies

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?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Ltd - Bella Vista
Recruitment postcode(s) [1] 0 0
2153 - Bella Vista

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.
Trial website
https://clinicaltrials.gov/study/NCT06769607
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sumudu Herath
Address 0 0
Country 0 0
Phone 0 0
+61 288841722
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06769607