Status:
COMPLETED
Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
This study will take between 1-2 months (with first patient first visit to last patient last visit). Each participant will use the supplied PAP device and mask for a period of up to 14 nights. Partici...
Detailed Description
The investigation device is designed to collect leak patterns which will be analysed to develop an advanced leak detection technology to help users/patients to troubleshhot therapy issues. This will ...
Eligibility Criteria
Inclusion
- Patients willing to give written informed consent.
- Patients who have a possible risk of mouth leak.
- Patients willing to give written consent for the recording of full band audio during sleep session.
- Patients who are willing to not wearing chin strap for a period of nights during study, if they currently use one.
- Patients who can read and comprehend English
- Patients who ≥ 18 years of age
- Patients being established on PAP therapy for the treatment of OSA for ≥ 6 months
- Patients currently using an appropriate mask system, AirFit P10, AirFit N20, AirFit N20, AirFit N30i (2 check version is correct) or similar mask (non-full face).
- Patients who can trial the investigational device for up to 14 nights
- Patients who have been compliant to therapy for the previous 7 nights of use.
Exclusion
- Patients willing to give written informed consent.
- Patients who have a possible risk of mouth leak.
- Patients willing to give written consent for the recording of full band audio during sleep session.
- Patients who are willing to not wearing chin strap for a period of nights during study, if they currently use one.
- Patients who can read and comprehend English
- Patients who ≥ 18 years of age
- Patients being established on PAP therapy for the treatment of OSA for ≥ 6 months
- Patients currently using an appropriate mask system, AirFit P10, AirFit N20, AirFit N20, AirFit N30i (2 check version is correct) or similar mask (non-full face).
- Patients who can trial the investigational device for up to 14 nights
- Patients who have been compliant to therapy for the previous 7 nights of use.
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04741854
Start Date
August 26 2020
End Date
March 12 2021
Last Update
October 16 2024
Active Locations (1)
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1
ResMed BELLA VISTA
Sydney, New South Wales, Australia, 2126