Clinical trial NCT06173050: PAP Systems Internal Clinical Studies (ICS)
Official title: Internal Evaluation of PAP Systems: Comparison of PAP Flow Generators Machines, Mask Systems and Tubing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is an open label, prospective, randomized cross over (or single arm) study designed to support the development of new accessories for PAP devices.
Primary purpose: TREATMENT

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.

Detailed description: This is an open label, prospective, randomized cross over (or single arm) study designed to support the 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, 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 are healthy volunteers who are ResMed employees. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Subjective outcomes parameters scores
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: