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

Sponsor
Fisher and Paykel Healthcare (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06060717
Collaborator
(none)
45
Enrollment
6.5
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: F&P Caramel
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the F&P Caramel Nasal Mask, US, 2023
Anticipated Study Start Date :
Nov 27, 2023
Anticipated Primary Completion Date :
Dec 11, 2023
Anticipated Study Completion Date :
Jun 11, 2024

Outcome Measures

Primary Outcome Measures

  1. Apnea-Hypopnea Index [14±5 days]

    Acceptable maintenance or lower (improved score) from baseline. Scores below 5 indicate a better outcome.

  2. Epworth Sleepiness Scale [14±5 days]

    Acceptable maintenance or lower (improved score) from baseline. Scores below 11 indicate a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fisher and Paykel Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT06060717
Other Study ID Numbers:
  • CIA-337
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Sleep Apnea, Obstructive

Study Results

No Results Posted as of Sep 29, 2023