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Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022

NCT05496062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2024-05-24

No results posted yet for this study

Summary

This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery.

The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

Conditions

Interventions

DEVICE

F&P Toffee Nasal and Toffee Nasal Pillows Masks

F\&P Toffee Nasal and Toffee Nasal Pillows Masks are intended to be used within the traditional PAP therapy system and are designed to facilitate equivalent PAP therapeutic efficacy as defined by standard practice.

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2022-10-07
Completion
2024-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05496062 on ClinicalTrials.gov