Development of Advanced Leak Detection Technologies for P... | NCT04741854

Studies
Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies

NCT04741854

Sponsor

ResMed

Status

Completed

Last Update Posted

Oct 16, 2024Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

Positive Airway Pressure (PAP) Therapy

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2020Actual

Primary Completion Date

Mar 12, 2021Actual

Completion Date

Mar 12, 2021Actual

First Submitted Date

Jan 11, 2021

First Submission Date that Met QC Criteria

Feb 3, 2021

First Posted Date

Feb 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2024

Last Update Posted Date

Oct 16, 2024Actual

Description Module

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.

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 be a multi-centre, multiphase, single arm study. The study will be conducted in the home environment.

Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the trial and those who wish to take part will be invited to ResMed for the first study visit.

Visit 1 Participants will provide written informed consent. If eligible, baseline participant demographics will be collected. Participants will be shown the investigation equipment. If the participant is happy to proceed, the therapy and comfort settings of the trial PAP device will be set-up to match their current PAP device and a mask similar to the participant's current mask will be provided to take home and be use in place of their own equipment.

Visit 2 After completing 7 days of the trial participants will return to the ResMed. The researcher will review the questionnaire and data quality with the participant.

Visit 2 may not be performed or completed via digital platform. For Phase 2 of this study. Visit 2 may not be completed as confidence in the system set up is achieved via Phase 1.

Visit 3

After completing another 7 days of the trial, participants will return to the ResMed. The participant will return all trial equipment researcher. The participants' questionnaire responses and data will be reviewed. This concludes the participation in the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational Device	Experimental	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.	Device: Positive Airway Pressure (PAP) Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Positive Airway Pressure (PAP) Therapy	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acoustic signals	Cross-correlation of acoustic signals recorded from the patient environment and the objective leak data recorded by the investigational Positive Airway Pressure Device.	2 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases