A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03272763
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 3.2

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: F&P Toffee mask	N/A

Detailed Description

This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.

This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).

The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 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: A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
• Actual Study Start Date: Oct 9, 2017
• Actual Primary Completion Date: Oct 29, 2017
• Actual Study Completion Date: Oct 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F&P Toffee mask Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.	Device: F&P Toffee mask; Trial Full-Face mask which comes with three seal sizes and two headgear sizes.

Outcome Measures

Primary Outcome Measures

1. Trial Mask Comfort [14 ± 5 days In-Home]

   Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective

2. Trial Mask Performance - Objective [14 ± 5 days In-Home]

   Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective

3. Trial Mask Performance - Subjective [14 ± 5 days In-Home]

   Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective

4. Trial Mask Usability [During Visit Two - 20 minutes]

   Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective

5. Trial Mask Ease-of-Use [14 ± 5 days In-Home]

   Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective

Secondary Outcome Measures

1. Mask Leak Data [14 ± 5 days In-Home]

   Leak data recorded from PAP device - Objective

2. Seal Size Determination [1 day-time appointment (1 hour) during Visit Two]

   Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.

3. Efficacy Data [14 ± 5 days In-Home]

   AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective

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 the diagnostic night

• Aged 22 and over (FDA defined as default)

• Either prescribed APAP, CPAP or Bi-level PAP for OSA

• Existing Full-Face mask user

• Fluent in spoken and written English

Exclusion Criteria:

• Inability to give informed consent

• Participant intolerant to PAP

• 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	California Sleep Solutions	Roseville	California	United States	95661

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 6, 2017

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT03272763
• Other Study ID Numbers: CIA-225
• First Posted: Sep 6, 2017
• Last Update Posted: Jun 21, 2022
• Last Verified: May 1, 2022

• 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 Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Period Title: Overall Study
STARTED	38
COMPLETED	38
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Overall Participants	38
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	38 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	16 42.1%
Male	22 57.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 10.5%
Not Hispanic or Latino	34 89.5%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Trial Mask Comfort
Description	Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	38
Much better	7 18.4%
Better	13 34.2%
Same	3 7.9%
Worse	12 31.6%
Much worse	3 7.9%

2. Primary Outcome

Title	Trial Mask Performance - Objective
Description	Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	38
Increased leak	9 23.7%
Same leak	3 7.9%
Decreased leak	9 23.7%
N/A	17 44.7%

3. Primary Outcome

Title	Trial Mask Performance - Subjective
Description	Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	38
Much better	9 23.7%
Better	8 21.1%
Same	10 26.3%
Worse	10 26.3%
Much worse	1 2.6%

4. Primary Outcome

Title	Trial Mask Usability
Description	Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
Time Frame	During Visit Two - 20 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	38
Both orientation and positioning	17 44.7%
Orientation only	25 65.8%
Neither	1 2.6%

5. Primary Outcome

Title	Trial Mask Ease-of-Use
Description	Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	38
Much better	7 18.4%
Better	14 36.8%
Same	13 34.2%
Worse	3 7.9%
Much worse	1 2.6%

6. Secondary Outcome

Title	Mask Leak Data
Description	Leak data recorded from PAP device - Objective
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	20
Leak increased	1 2.6%
Leak remained the same	3 7.9%
Leak decreased	10 26.3%
No data	6 15.8%

7. Secondary Outcome

Title	Seal Size Determination
Description	Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.
Time Frame	1 day-time appointment (1 hour) during Visit Two

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	38
Yes	36 94.7%
No	2 5.3%

8. Secondary Outcome

Title	Efficacy Data
Description	AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
Measure Participants	38
AHI increased	18 47.4%
AHI remained the same	3 7.9%
AHI decreased	14 36.8%
No data	3 7.9%

Adverse Events

Time Frame	Adverse event data was collected for all participants for 1 year from the date informed consent was obtained.
Arm/Group Title	F&P Toffee Mask
Arm/Group Description	Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
All Cause Mortality
	F&P Toffee Mask
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Serious Adverse Events
	F&P Toffee Mask
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Other (Not Including Serious) Adverse Events
	F&P Toffee Mask
	Affected / at Risk (%)	# Events
Total	2/38 (5.3%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion and sore	2/38 (5.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.