A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: F&P Toffee mask

Detailed Description

This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.

This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).

The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.

The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Roseville, California, United States, 95661
      • California Sleep Solutions

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• AHI ≥ 5 from the diagnostic night
• Aged 22 and over (FDA defined as default)
• Either prescribed APAP, CPAP or Bi-level PAP for OSA
• Existing Full-Face mask user
• Fluent in spoken and written English

Exclusion Criteria:

• Inability to give informed consent
• Participant intolerant to PAP
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or CO2 retention
• Pregnant or think they may be pregnant

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 mask; Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.	Device: F&P Toffee mask; Trial Full-Face mask which comes with three seal sizes and two headgear sizes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial Mask Comfort	Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective	14 ± 5 days In-Home
Trial Mask Performance - Objective	Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective	14 ± 5 days In-Home
Trial Mask Performance - Subjective	Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective	14 ± 5 days In-Home
Trial Mask Usability	Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective	During Visit Two - 20 minutes
Trial Mask Ease-of-Use	Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective	14 ± 5 days In-Home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mask Leak Data	Leak data recorded from PAP device - Objective	14 ± 5 days In-Home
Seal Size Determination	Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.	1 day-time appointment (1 hour) during Visit Two
Efficacy Data	AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective	14 ± 5 days In-Home

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): October 29, 2017
• Study Completion (Actual): October 9, 2018

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CIA-225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be available to other researchers or institutions. Identifiable participant data will not leave the site and all other data will be de-identified.

Drug and device information, study documents

• 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