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

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04011826
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Device: Trial nasal mask (F&P)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: After a period of baseline, all enrolled participants will be put on the same trial mask.After a period of baseline, all enrolled participants will be put on the same trial mask.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
• Actual Study Start Date: Aug 5, 2019
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Aug 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Objective Trial Mask Performance [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.

Secondary Outcome Measures

1. Number of Participants Trial Mask Overall Simplicity of Use [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.

2. Number of Participants Subjective Trial Mask Comfort [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.

3. Number of Participants Overall Trial Mask Satisfaction [14 ± 3 days in home]

   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 ).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clayton Sleep Institute	Saint Louis	Missouri	United States	63143

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

• Principal Investigator: Mark Muehlbach, Clinical Director

Study Documents (Full-Text)

• Study Protocol - Oct 17, 2019

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT04011826
• Other Study ID Numbers: CIA-262
• First Posted: Jul 9, 2019
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

Participant Flow

Arm/Group Title	Experimental: Experimental Trial Nasal Mask
Arm/Group Description	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.
Period Title: Overall Study
STARTED	45
COMPLETED	45
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Experimental: Experimental Trial Nasal Mask
Arm/Group Description	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 Participants	45
Age, Customized (Count of Participants)
Age 22+ years	45 100%
Sex: Female, Male (Count of Participants)
Female	16 35.6%
Male	29 64.4%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	32 71.1%
Other ethnicity (Hispanic/African American/Asian/Polynesian Descent	13 28.9%
Region of Enrollment (participants) [Number]
United States	45 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Objective Trial Mask Performance
Description	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.
Time Frame	14 ± 3 days in home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Experimental Trial Nasal Mask
Arm/Group Description	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.
Measure Participants	42
Count of Participants [Participants]	42 93.3%

2. Secondary Outcome

Title	Number of Participants Trial Mask Overall Simplicity of Use
Description	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.
Time Frame	14 ± 3 days in home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Experimental Trial Nasal Mask
Arm/Group Description	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.
Measure Participants	45
Very Simple	53 117.8%
Simple	36 80%
Average	2 4.4%
Challenging	7 15.6%
Very Challenging	2 4.4%

3. Secondary Outcome

Title	Number of Participants Subjective Trial Mask Comfort
Description	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.
Time Frame	14 ± 3 days in home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Experimental Trial Nasal Mask
Arm/Group Description	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.
Measure Participants	45
Very comfortable	39 86.7%
Comfortable	37 82.2%
Average	11 24.4%
Uncomfortable	11 24.4%
Very uncomfortable	2 4.4%

4. Secondary Outcome

Title	Number of Participants Overall Trial Mask Satisfaction
Description	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 ).
Time Frame	14 ± 3 days in home

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Experimental: Experimental Trial Nasal Mask
Arm/Group Description	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.
Measure Participants	44
Preferred F&P nasal mask	24 53.3%
Did not prefer F&P nasal mask	20 44.4%

Adverse Events

Time Frame	6 Months
Arm/Group Title	Experimental: Experimental Trial Nasal Mask
Arm/Group Description	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.
All Cause Mortality
	Experimental: Experimental Trial Nasal Mask
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Serious Adverse Events
	Experimental: Experimental Trial Nasal Mask
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	Experimental: Experimental Trial Nasal Mask
	Affected / at Risk (%)	# Events
Total	5/45 (11.1%)
General disorders
Pain in Left Leg	1/45 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
Sinus Headaches	1/45 (2.2%)	1
Cold	1/45 (2.2%)	1
Skin and subcutaneous tissue disorders
Rawness on side of nose	1/45 (2.2%)	1
Surgical and medical procedures
Pre-scheduled Cataract Surgery	1/45 (2.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.