Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment

Evaluating the Efficacy of Positive Airway Pressure Therapy for Treating Obstructive Sleep Apnea in the Home Environment

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Positive Airway Pressure (PAP) Therapy

Detailed Description

A new PAP device has been developed by ResMed which includes an improved humidification system, a new user interface and optimized workflows. This study will assess the efficacy and usability of the new PAP device in an OSA population.

This is a prospective, open-label, single arm study, multi-site study to assess the usability and efficacy of investigational device in the home environment.

Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the study and those who wish to take part will be invited to a ResMed clinic or selected site for the first study visit (As detailed in section 7).

Visit 1 Participants will provide written informed consent (as per section 6.1). If eligible, baseline participant demographics will be collected. Participants will be shown the investigation device. If the participant is happy to proceed the investigational device will be set-up to be exactly the same as their current CPAP device, and the participant will take it home to use in place of their own device.

Visit 2 At the conclusion of the 7 nights of use, the participant will be asked to fill in a questionnaire documenting their experience with the investigational device. The participant will return all study equipment to the researcher. The questionnaires will be reviewed. This concludes the participation in the study.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2153
      • ResMed BELLA VISTA
• United States
  • California
    • San Diego, California, United States, 92123
      • Sleep Data

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Subjective ratings of the Usability of the Pacific device after using it in the home environment for up to 7 nights. Ratings will be collected using an 11 point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index (AHI)	Number of residual Apnea Hypopnea events within a clinically acceptable range when using the Pacific device in the home environment for a up to 7 nights.	1 week
Usage-Positive Airway Pressure (PAP) Device parameters	Average number of hours per night of use of the Pacific Device during sleep sessions from up to 7 nights	1 week
Leak-Positive Airway Pressure (PAP) Device parameters	Average median, 95 percentile and maximum leak(L/min) while using the Pacific device from up to 7 nights	1 week
Pressure-Positive Airway Pressure (PAP) Device parameters	Average pressure delivered by the Pacific device between 4cmH2O-20cmH2O from use up to 7 nights	1 week
Acoustic Signals	Cross-correlation of the acoustic signals recorded from the patient environment and the external recording in the controlled laboratory environment identification algorithm.	1 week

Collaborators and Investigators

• Sponsor: ResMed

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): March 5, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: SLP-20-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes