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

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03329352
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: F&P Full-Face Mask	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 44 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: Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
• Actual Study Start Date: Nov 3, 2017
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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

3. Trial Mask Seal Performance - Subjective [14 ± 5 days in-home]

   Determined from questionnaire - Subjective Uses a 5 point Likert Scale

4. 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.

5. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Texas Lung and Sleep Clinic	Fort Worth	Texas	United States	76109

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

• Principal Investigator: David Ostransky, MD, Board Certified Sleep Specialist

Study Documents (Full-Text)

• Study Protocol - Sep 1, 2017

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT03329352
• Other Study ID Numbers: CIA-227
• First Posted: Nov 6, 2017
• Last Update Posted: Nov 10, 2021
• Last Verified: Oct 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	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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).
Period Title: F&P Toffee Full Face Mask Validation
STARTED	44
COMPLETED	42
NOT COMPLETED	2
Period Title: F&P Toffee Full Face Mask Validation
STARTED	29
COMPLETED	22
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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.
Overall Participants	42
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	42 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	10 23.8%
Male	32 76.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	42 100%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	42 100%

Outcome Measures

1. Primary Outcome

Title	Trial Mask Comfort
Description	Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Time Frame	14 ± 5 days in-home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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.
Measure Participants	42
Very comfortable	20 47.6%
Comfortable	16 38.1%
Neutral	4 9.5%
Uncomfortable	1 2.4%
Very uncomfortable	0 0%
N/A	1 2.4%

2. Primary Outcome

Title	Participant Count of Acceptable Trial Mask Performance - Objective
Description	Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective
Time Frame	14 ± 5 days in-home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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).
Measure Participants	42
Pass	34 81%
Fail	0 0%
N/A	8 19%

3. Primary Outcome

Title	Trial Mask Seal Performance - Subjective
Description	Determined from questionnaire - Subjective Uses a 5 point Likert Scale
Time Frame	14 ± 5 days in-home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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).
Measure Participants	42
Very good	17 40.5%
Good	14 33.3%
Neutral	4 9.5%
Poor	4 9.5%
Very poor	2 4.8%
N/A	1 2.4%

4. Primary Outcome

Title	Trial Mask Ease of Cleaning
Description	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.
Time Frame	14 ± 5 days in-home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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.
Measure Participants	42
Very easy	25 59.5%
Easy	15 35.7%
Neutral	2 4.8%
Hard	0 0%
Very hard	0 0%

5. Primary Outcome

Title	Trial Mask Ease-of-use
Description	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.
Time Frame	14 ± 5 days in-home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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).
Measure Participants	42
Very easy	27 64.3%
Easy	14 33.3%
Neutral	1 2.4%
Hard	0 0%
Very hard	0 0%

6. Secondary Outcome

Title	Participant Count of Acceptable Mask Leak
Description	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.
Time Frame	14 ± 5 days in-home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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.
Measure Participants	42
Pass	30 71.4%
Fail	4 9.5%
N/A	8 19%

7. Secondary Outcome

Title	Participant Count of Seal Size Determination
Description	Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.
Time Frame	1 day-time appointment (1 hour) Visit 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Full-Face Mask
Arm/Group Description	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. F&P Toffee Full-Face Mask: The F&P Toffee 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).
Measure Participants	44
Pass	28 66.7%
Fail	16 38.1%

Adverse Events

Time Frame	Adverse event data was collected over the 6 months the trial ran for (including the extension)
Arm/Group Title	F&P Full-Face Mask
Arm/Group Description	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. 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. Adverse event data will be collated for both arms of the trial for simplicity.
All Cause Mortality
	F&P Full-Face Mask
	Affected / at Risk (%)	# Events
Total	0/42 (0%)
Serious Adverse Events
	F&P Full-Face Mask
	Affected / at Risk (%)	# Events
Total	2/42 (4.8%)
Blood and lymphatic system disorders
Pulmonary embolism	1/42 (2.4%)	1
Cardiac disorders
Myocardial infarction	1/42 (2.4%)	1
Other (Not Including Serious) Adverse Events
	F&P Full-Face Mask
	Affected / at Risk (%)	# Events
Total	2/42 (4.8%)
Skin and subcutaneous tissue disorders
Facial irritation	2/42 (4.8%)	2

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.