Evaluation of the F&P Caramel Nasal Mask, US, 2023

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluation of the F&P Caramel Nasal Mask, US, 2023

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06060717
• Other study ID #: CIA-337
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: June 11, 2024

Study information

• Verified date: September 2023
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 11, 2024
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Persons who are =22 years of age

• Persons who weigh =66 pounds

• Persons who have been prescribed PAP therapy by a physician

• Persons who are existing nasal mask or sub-nasal mask users with =3 months of use prior to enrolment in the clinical trial

• Persons who are compliant with PAP therapy for =4 hours per night for =70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial

• Persons who are fluent in spoken and written English

• Persons who possess the capacity to provide informed consent

Exclusion Criteria:

• Persons who are intolerant to PAP therapy

• Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate

• Persons who are required to use PAP therapy for >12 hours per day or for extensive periods, not including sleep or naps

• Persons who are trying to get pregnant, are pregnant, or think they may be pregnant

• Persons who have an IPAP pressure of >30 cmH2O if on BPAP

• Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen

• Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• F&P Caramel
Nasal mask

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index	Acceptable maintenance or lower (improved score) from baseline. Scores below 5 indicate a better outcome.	14±5 days
Primary	Epworth Sleepiness Scale	Acceptable maintenance or lower (improved score) from baseline. Scores below 11 indicate a better outcome.	14±5 days