Trial Outcomes & Findings for The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea (NCT NCT04011826)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

14 ± 3 days in home

Results posted on

2021-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	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: 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.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Experimental Trial Nasal Mask n=45 Participants 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: 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.
Age, Customized Age 22+ years	45 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	32 Participants n=5 Participants
Race/Ethnicity, Customized Other ethnicity (Hispanic/African American/Asian/Polynesian Descent	13 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 ± 3 days in home

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.

Outcome measures

Outcome measures
Measure	Experimental: Experimental Trial Nasal Mask n=42 Participants 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: 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.
Number of Participants Objective Trial Mask Performance	42 Participants

SECONDARY outcome

Timeframe: 14 ± 3 days in home

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.

Outcome measures

Outcome measures
Measure	Experimental: Experimental Trial Nasal Mask n=45 Participants 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: 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.
Number of Participants Trial Mask Overall Simplicity of Use Very Simple	53 percentage of participants
Number of Participants Trial Mask Overall Simplicity of Use Simple	36 percentage of participants
Number of Participants Trial Mask Overall Simplicity of Use Average	2 percentage of participants
Number of Participants Trial Mask Overall Simplicity of Use Challenging	7 percentage of participants
Number of Participants Trial Mask Overall Simplicity of Use Very Challenging	2 percentage of participants

SECONDARY outcome

Timeframe: 14 ± 3 days in home

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.

Outcome measures

Outcome measures
Measure	Experimental: Experimental Trial Nasal Mask n=45 Participants 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: 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.
Number of Participants Subjective Trial Mask Comfort Very uncomfortable	2 percentage of participants
Number of Participants Subjective Trial Mask Comfort Very comfortable	39 percentage of participants
Number of Participants Subjective Trial Mask Comfort Comfortable	37 percentage of participants
Number of Participants Subjective Trial Mask Comfort Average	11 percentage of participants
Number of Participants Subjective Trial Mask Comfort Uncomfortable	11 percentage of participants

SECONDARY outcome

Timeframe: 14 ± 3 days in home

Population: A data size of 44 was used for this analysis due to missing data for one participant.

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 ).

Outcome measures

Outcome measures
Measure	Experimental: Experimental Trial Nasal Mask n=44 Participants 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: 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.
Number of Participants Overall Trial Mask Satisfaction Preferred F&P nasal mask	24 Participants
Number of Participants Overall Trial Mask Satisfaction Did not prefer F&P nasal mask	20 Participants

Adverse Events

Experimental: Experimental Trial Nasal Mask

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental: Experimental Trial Nasal Mask n=45 participants at risk 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: 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.
Respiratory, thoracic and mediastinal disorders Sinus Headaches	2.2% 1/45 • Number of events 1 • 6 Months
Skin and subcutaneous tissue disorders Rawness on side of nose	2.2% 1/45 • Number of events 1 • 6 Months
Respiratory, thoracic and mediastinal disorders Cold	2.2% 1/45 • Number of events 1 • 6 Months
General disorders Pain in Left Leg	2.2% 1/45 • Number of events 1 • 6 Months
Surgical and medical procedures Pre-scheduled Cataract Surgery	2.2% 1/45 • Number of events 1 • 6 Months

Additional Information

Clinical Research Scientist

Fisher and Paykel Healthcare

Phone: +64 09 574 0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place