The Evaluation of a New Nasal 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: Device: Trial nasal mask (F&P)

Detailed Description

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited.

The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63143
      • Clayton Sleep Institute

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:

• Diagnosis of OSA by Physician
• ≥ 22 years of age
• ≥ 66 lbs
• Prescribed PAP or BPAP therapy for OSA
• Existing nasal, sub-nasal and pillows mask users
• Fluent in written and spoken English

Exclusion Criteria:

• Inability to give informed consent
• Pregnant or think they may be pregnant
• PAP Intolerant
• Anatomical or Physiological Conditions that make PAP inappropriate
• IPAP pressure of ≤25cmH20.
• PAP/BPAP therapy device without data recording capabilities
• Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen

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: Experimental: Experimental trial nasal mask; Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. Participants on the extension will use this trial mask for a further six months after Visit 3.	Device: Device: Trial nasal mask (F&P); This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.; Other Names: New nasal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Objective Trial Mask Performance	Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device. Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F&P nasal mask.	14 ± 3 days in home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Trial Mask Overall Simplicity of Use	Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging). Results below represent percentage of respondents for each value.	14 ± 3 days in home
Number of Participants Subjective Trial Mask Comfort	Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable). Participants reported their subject views on mask comfort. Responses to each likert scale option are presented below as percentages.	14 ± 3 days in home
Number of Participants Overall Trial Mask Satisfaction	Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F&P Nasal mask compared to participants' usual mask ).	14 ± 3 days in home

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Mark Muehlbach, Clinical Director

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

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-262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared with any other researchers or organizations.

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