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

NCT05496062 | Completed FDA Device

• 1 other identifier: CIA-305
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea

Keywords

Positive Airway Pressure Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comfort

  After two weeks of use

Study Arms (1)

F&P Toffee Nasal and Toffee Nasal Pillows Mask

EXPERIMENTAL

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

Interventions

F&P Toffee Nasal and Toffee Nasal Pillows Masks 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.

F&P Toffee Nasal and Toffee Nasal Pillows Mask

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons who are ≥ 22 years of age
• Persons who weigh ≥ 66 lbs (30 kgs)
• Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
• 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
• Persons who are currently using either a nasal, sub-nasal or nasal pillows mask
• Persons who have an IPAP pressure of \< 20 cmH2O
• Persons who currently use a PAP therapy device with data recording capabilities
• Persons who are fluent in spoken and written English
• Persons who possess the capacity to provide informed consent

You may not qualify if:

• Persons who are intolerant to PAP therapy
• Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
• Persons using full face masks
• Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Persons who are pregnant or think they may be pregnant
• Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (2)

Clinical Site Partners, LLC - DBA CSP Miami

Miami, Florida, 33186, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: September 12, 2022
• Primary Completion: October 7, 2022
• Study Completion: April 30, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (2)