PAP Systems Internal Clinical Studies (ICS)

NCT06173050 | Completed DMC

• 1 other identifier: SLP-23-10-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Subjective outcomes parameters scores

  Subjective outcomes parameters scores from participants. Each subjective outcomes item of the investigational component/s of the PAP System will be rated on a Likert Scale questionnaire. Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.

  6 weeks

Study Arms (2)

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

OTHER

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 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 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) DEVICE

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

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 who are employees of ResMed
• Participants shall be volunteers
• Participants willing to give written informed consent
• Participants who ≥ 18 years of age
• Participants willing and able to complete the specified tasks

You may not qualify if:

• 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.

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Resmed Asia Pacific Pte Ltd

Singapore, Singapore

Location

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

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: This 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: November 9, 2023
• First Posted: December 15, 2023
• Study Start: June 20, 2024
• Primary Completion: July 22, 2024
• Study Completion: July 25, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)