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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/NCT04744038




Registration number
NCT04744038
Ethics application status
Date submitted
4/01/2021
Date registered
8/02/2021
Date last updated
13/07/2021

Titles & IDs
Public title
Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
Scientific title
Evaluating the Efficacy of Positive Airway Pressure Therapy for Treating Obstructive Sleep Apnea in the Home Environment
Secondary ID [1] 0 0
SLP-20-01-01
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 then 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. Participants will use their own mask with the investigational device for the duration of this study.


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
Usability
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Apnea Hypopnea Index (AHI)
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Usage-Positive Airway Pressure (PAP) Device parameters
Timepoint [2] 0 0
1 week
Secondary outcome [3] 0 0
Leak-Positive Airway Pressure (PAP) Device parameters
Timepoint [3] 0 0
1 week
Secondary outcome [4] 0 0
Pressure-Positive Airway Pressure (PAP) Device parameters
Timepoint [4] 0 0
1 week
Secondary outcome [5] 0 0
Acoustic Signals
Timepoint [5] 0 0
1 week

Eligibility
Key inclusion criteria
- Patients willing to give written informed consent

- 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 AirSense10 (as their primary device)

- Patients currently using an appropriate mask system (AirFit F20, AirFit P10, AirFit
N20, AirFit N30i, AirFit F30i or AirFit P30i)

- Patients who can trial the investigational device for up to 7 nights

- Patients who have been compliant to therapy (average of =4 hours of usage) for the
previous 7 nights of use* *the most recent consecutive 7 nights within the last 30
days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients using Bilevel flow generators

- Patients who are or may be pregnant

- Patients 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.

- Patients believed to be unsuitable for inclusion by the researcher

- Patients who or whose bed partner has implantable metallic implants in the head, neck
and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)

- Patients using supplemental oxygen

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2021
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed BELLA VISTA - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

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 4-6 months (with first patient first visit to last patient last
visit expected to span 3-4 months across all study sites). Each participant will use the
investigational PAP device with their own mask for a period of up to 7 nights and will
complete a series of questionnaires upon completion. The study will evaluate the usability
and efficacy of the investigational device in the intended use environment by the intended
use population.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04744038
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04744038