Obstructive Sleep Apnea
Conditions
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.
Interventions
PAP System A (with Amalfi) for 7 days followed by PAP System B (with CLA11) for 7 days
PAP System B (with CLA11) for 7 days followed by PAP System A (with Amalfi) for 7 days
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
Yes
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 (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective outcomes parameters scores | 6 weeks | 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. |
Countries
Singapore
Outcome results
None listed