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

NCT04741854 | Completed

• 1 other identifier: SLP-20-04-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

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.

Investigational Device

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

ResMed BELLA VISTA

Sydney, New South Wales, 2126, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: February 5, 2021
• Study Start: August 26, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)