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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04741854




Registration number
NCT04741854
Ethics application status
Date submitted
11/01/2021
Date registered
5/02/2021
Date last updated
5/02/2021

Titles & IDs
Public title
Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
Scientific title
Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
Secondary ID [1] 0 0
SLP-20-04-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 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 - Positive Airway Pressure (PAP) Therapy

Experimental: Investigational Device - Participants will be asked to take home the investigational device to use at night while they sleep in place of their own device. The participant's therapy and comfort settings will be copied from their own device to the investigational device.


Treatment: Devices: Positive Airway Pressure (PAP) Therapy
PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acoustic signals
Timepoint [1] 0 0
2 Months

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2021
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed BELLA VISTA - Sydney
Recruitment postcode(s) [1] 0 0
2126 - Sydney

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

Ethics approval
Ethics application status

Summary
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. Participants will complete a series of questionnaires. The study will collect data to
support the development of an advance leak detection technology.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04741854
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 M Herath
Address 0 0
Country 0 0
Phone 0 0
0435 528 615
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/ct2/show/NCT04741854