PAP Systems External Clinical Studies (ECS)

April 22, 2026 updated by: ResMed

External Evaluation of PAP Systems: Comparison of PAP Flow Generators Machines, Mask Systems and Tubing

This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open label, prospective, randomized cross over (or single arm) study for ongoing product development of new accessories for PAP devices. This generic protocol provides a framework methodology for how these ongoing studies will be conducted. This protocol then is used in a number of smaller sub-studies phases, each of which will have their own sub-protocol outlining the exact specifics of the study.

The studies could be run face-to-face or remotely.

Participants who met the inclusion/exclusion criteria will be contacted. Recruitment will be done via emails. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.

Visit 1: Participants will provide written informed consent. Participants will be shown the PAP systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the PAP systems. If the participant and assessor are happy to proceed, the participants will use the loan PAP system for trial.

Visit 2: After trialing the PAP systems, participants will be asked to complete a questionnaire regarding the appeal, comfort, and usability of the PAP system(s). Depending on sub-study protocol, participants will then take the second PAP system home to test.

Visit 3: The participant will return the loan PAP system to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants willing to give written informed consent
  • Participants who ≥ 18 years of age
  • Participants being treated for OSA for ≥ 3 months
  • Participants currently using a suitable PAP system(s)
  • Participants who can trial the PAP systems for up to 7 nights each

Additional criteria for remote studies:

  • Participants currently using PAP device compatible with AirView, or with download capacity from PAP machine from data cards
  • Participants who have access to video call equipment

Exclusion Criteria:

  • Participants using Bilevel flow generators
  • Participants who are or may be pregnant
  • Participants 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.
  • Participants believed to be unsuitable for inclusion by the researcher
  • Participants who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
  • Participants who are currently enrolled in other clinical studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PAP System B (with CLA11) then PAP System A (with Amalfi)
Participants will be asked to take home the comparator PAP system B (CLA 11) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System B and PAP System A. This arm will first use the CLA 11 for 7 days and then use the Amalfi for 7 days.
Device: PAP System A (with Amalfi) then PAP System B (with CLA11)
PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days
Device: PAP System B (with CLA11) then PAP System A (with Amalfi)
PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days
Experimental: PAP System A (with Amalfi) then PAP System B (with CLA11)
Participants will be asked to take home the investigational PAP system (Amalfi) to use at night while they sleep in place of their own PAP system. The participant's therapy and comfort settings will not be altered. Participants will be randomized as to the order they will trial PAP System A and PAP System B. This arm will first use the Amalfi for 7 days and then use the CLA 11 for 7 days.
Device: PAP System A (with Amalfi) then PAP System B (with CLA11)
PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days
Device: PAP System B (with CLA11) then PAP System A (with Amalfi)
PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(usability) Comparison of the usability of an investigational component/s of the PAP system to a comparison component/s of the PAP system and/or Criterion Score of 6
Time Frame: 6 weeks

Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or Criterion Score of 6

Subjective usability scores will be collected from participants on each usability item (e.g., comfort, seal, ease of use). Scores 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
6 weeks
(efficacy) Comparison of the investigational component/s of the PAP system efficacy (AHI) to a comparison component/s of the PAP system and/or clinically relevant data
Time Frame: 6 weeks

Hypothesis: The investigational component/s of the PAP system will be equivalent to the comparison component/s of the PAP system and/or clinically relevant data

Objective data stored in the CPAP device will be downloaded wirelessly using a computer program (AirView or ResScan, ResMed). An Apnea hypopnea index (AHI) automatically analyzed by the program will be used. Typically, an AHI <5 demonstrates efficacious treatment.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2028

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 29, 2028

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLP-24-08-01

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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