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

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Positive Airway Pressure (PAP) Therapy
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ResMed BELLA VISTARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Device

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2021
Last Updated
February 3, 2021
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT04741854
Brief Title
Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
Official Title
Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Positive Airway Pressure (PAP) Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acoustic signals
Description
Cross-correlation of acoustic signals recorded from the patient environment and the objective leak data recorded by the investigational Positive Airway Pressure Device.
Time Frame
2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sumudu M Herath
Phone
0435 528 615
Email
sumudu.herath@resmed.com.au
Facility Information:
Facility Name
ResMed BELLA VISTA
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2126
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumudu Herath
Email
sumudu.herath@resmed.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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