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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: F&P Full-Face Mask

• Registration Number: NCT03329352
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study Start: 2017-11-03
• Study First Posted: 2017-11-06
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Disposition First Submitted: 2020-06-30
• Results First Submitted: 2021-06-14
• Results First Submitted QC: 2021-08-25
• Disposition First Submitted QC: 2021-08-25
• Results First Posted: 2021-09-21
• Disposition First Posted: 2021-09-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F&P Full-Face Mask	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.

Primary Outcome Measures

Name	Time	Method
Trial Mask Comfort	14 ± 5 days in-home	Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Participant Count of Acceptable Trial Mask Performance - Objective	14 ± 5 days in-home	Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective
Trial Mask Seal Performance - Subjective	14 ± 5 days in-home	Determined from questionnaire - Subjective Uses a 5 point Likert Scale
Trial Mask Ease of Cleaning	14 ± 5 days in-home	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.
Trial Mask Ease-of-use	14 ± 5 days in-home	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.

Secondary Outcome Measures

Name	Time	Method
Participant Count of Acceptable Mask Leak	14 ± 5 days in-home	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.
Participant Count of Seal Size Determination	1 day-time appointment (1 hour) Visit 2	Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.

Trial Locations

Locations (1)

North Texas Lung and Sleep Clinic; 🇺🇸 Fort Worth, Texas, United States