Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)

The 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 Full-Face Mask

Detailed Description

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face 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 full-face mask by a sleep technician for use in-home (Visit 2). The participant then will 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 trial full-face 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 phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months.

The mask and CPAP (if used from the loan 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 Obstructive Sleep Apnea.

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

Data from initial 2 week trial is reported here.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76109
      • North texas Lung and Sleep Clinic

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 diagnostic PSG night
• Aged 22 and over (FDA defined as adult)
• Either prescribed APAP, CPAP or Bi-Level PAP for OSA
• Existing full-face mask users
• Fluent in spoken and written English

Exclusion Criteria:

• Inability to give informed consent
• Patient intolerant to CPAP therapy
• 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 Full-Face Mask; Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.	Device: F&P Full-Face Mask; The F&P full-face mask will serve as the participant's primary PAP 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 full-face mask as their primary PAP therapy mask for 6 months after Visit 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial Mask Comfort	Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).	14 ± 5 days in-home
Participant Count of Acceptable Trial Mask Performance - Objective	Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective	14 ± 5 days in-home
Trial Mask Seal Performance - Subjective	Determined from questionnaire - Subjective Uses a 5 point Likert Scale	14 ± 5 days in-home
Trial Mask Ease of Cleaning	Determined from questionnaires - Subjective A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.	14 ± 5 days in-home
Trial Mask Ease-of-use	Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.	14 ± 5 days in-home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Count of Acceptable Mask Leak	Data recorded from PAP device reporting amount of air leaking from the mask during PAP therapy. If mask leak was over 60 L/min it was compared to the participants baseline leak values to assess if mask leak with the trial mask was acceptable or not.	14 ± 5 days in-home
Participant Count of Seal Size Determination	Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.	1 day-time appointment (1 hour) Visit 2

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 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-227

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