PAP Systems External Clinical Studies (ECS)

Sponsor
ResMed
Study ID
NCT06562205
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Accepted

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 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

Study Details

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

Key Dates

First listed
Aug 20, 2024
Start date
Aug 1, 2028
Status verified
Apr 2026
Primary completion
Oct 1, 2028
Completion
Oct 29, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

(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 ]

Central Contacts

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