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

NCT ID: NCT05496062

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2024-04-30

Brief 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.

Detailed Description

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. A target recruitment goal of 45, current PAP therapy users per mask type (e.g. Nasal and Nasal Pillows) will be recruited to participate in this investigation to achieve a total sample of 90. The investigation will involve participation in a two week in home trial of the F&P Toffee Nasal or Toffee Nasal Pillows mask.

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

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

F&P Toffee Nasal and Toffee Nasal Pillows Mask

Participants will be placed in the experimental arm for 14 days, during which they will be using either the Toffee Nasal or Toffee Nasal Pillows mask for PAP therapy.

Group Type: EXPERIMENTAL

F&P Toffee Nasal and Toffee Nasal Pillows Masks

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Persons who are ≥ 22 years of age

2. Persons who weigh ≥ 66 lbs (30 kgs)

3. Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician

4. Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial

5. Persons who are currently using either a nasal, sub-nasal or nasal pillows mask

6. Persons who have an IPAP pressure of < 20 cmH2O

7. Persons who currently use a PAP therapy device with data recording capabilities

8. Persons who are fluent in spoken and written English

9. Persons who possess the capacity to provide informed consent

Exclusion Criteria

1. Persons who are intolerant to PAP therapy

2. Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps

3. Persons using full face masks

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

5. Persons who are pregnant or think they may be pregnant

6. Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Site Partners, LLC - DBA CSP Miami

Miami, Florida, United States

Clayton Sleep Institute

St Louis, Missouri, United States

Countries

United States

Other Identifiers

CIA-305

Identifier Type: -

Identifier Source: org_study_id