PAP Systems External Clinical Studies (ECS)

NCT06562205 | Not Yet Recruiting DMC

• 1 other identifier: SLP-24-08-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• (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

  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

  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

Study Arms (2)

PAP System A (with Amalfi) then PAP System B (with CLA11)

EXPERIMENTAL

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); Device: PAP System B (with CLA11) then PAP System A (with Amalfi)

PAP System B (with CLA11) then PAP System A (with Amalfi)

ACTIVE COMPARATOR

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); Device: PAP System B (with CLA11) then PAP System A (with Amalfi)

Interventions

PAP System A (with Amalfi) then PAP System B (with CLA11) DEVICE

PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days

PAP System A (with Amalfi) then PAP System B (with CLA11); PAP System B (with CLA11) then PAP System A (with Amalfi)

PAP System B (with CLA11) then PAP System A (with Amalfi) DEVICE

PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days

PAP System A (with Amalfi) then PAP System B (with CLA11); PAP System B (with CLA11) then PAP System A (with Amalfi)

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 who are currently enrolled in other clinical studies

Sponsors & Collaborators

• ResMed: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xueling Zhu Manager - Clinical Data and Operations

CONTACT

+61288842367; xueling.zhu@resmed.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: his is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start (Estimated): August 1, 2028
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 29, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share