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

NCT ID: NCT04741854

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-26
• Study Completion Date: 2021-03-12

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Positive Airway Pressure (PAP) Therapy

Intervention Type: 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.

Interventions

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 Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ResMed BELLA VISTA

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

SLP-20-04-01

Identifier Type: -

Identifier Source: org_study_id