Evaluation of the F&P Mask, US, 2026
A legfontosabb adatok
- Hol
- St Louis (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Clayton Sleep InstituteSt Louis, Egyesült ÁllamokContact: Matthew UhlesRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Fisher and Paykel Healthcare
- Azonosító
- NCT07826429
- A regiszteradat frissítve
- 2026. október 16.
- Eredeti leírás
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.A teljes eredeti leírásKevesebb
Evaluation of the F&P PAP Mask, US, 2026
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.
Bevonási feltételek: Are ≥22 years of age; Weigh ≥66 pounds; Have been prescribed PAP/NIV therapy by a physician; Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation*; Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation; Are fluent in spoken and written English; Possess the capacity to provide informed consent.
Kizáró feltételek: Are intolerant to PAP/NIV therapy; Are required to use PAP/NIV therapy for >12 hours per day or for extensive periods, not including sleep or naps; Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2; Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site; Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate; Have a history of light-induced seizures (for optional anthropometric scan only); Are trying to get pregnant, are pregnant, or think they may be pregnant; Have an IPAP pressure of >30 cmH2O if on BPAP.