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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: F&P Toffee Nasal and Toffee Nasal Pillows Masks

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33186
      • Clinical Site Partners, LLC - DBA CSP Miami
  • Missouri
    • Saint Louis, Missouri, United States, 63123
      • Clayton Sleep Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Efficacy	The F&P Toffee Nasal and Toffee Nasal Pillows masks provides adequate PAP therapy when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines after 14 days of use.	After two weeks of use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	The F&P Toffee Nasal and Toffee Nasal Pillows is comfortable during PAP therapy when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire after 14 days of use.	After two weeks of use

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): October 7, 2022
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Positive Airway Pressure Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIA-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes