PAP Systems External Clinical Studies (ECS)

ConditionObstructive Sleep Apnea

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-130

SponsorResMed

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: PAP System A (with Amalfi) then PAP System B (with CLA11)Experimental treatment 2 interventions

Group B: PAP System B (with CLA11) then PAP System A (with Amalfi)Active comparator 2 interventions

Trial outcomes

Primary outcomes

(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

Time frame

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.

Time frame

6 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ResMed

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: