A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03124069
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.2
• Patients Per Site Per Month: 7.1

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 Saturn	N/A

Detailed Description

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited

This study will involve a baseline (Visit One) 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 for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give 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 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 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 Nasal Mask for the Treatment of Obstructive Sleep Apnea
• Actual Study Start Date: Apr 24, 2017
• Actual Primary Completion Date: May 26, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F&P Saturn Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.	Device: F&P Saturn; Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Comfort Compared to Their Usual Mask. [14 ± 5 days In-Home]

   Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

2. Number of Participants PAP Device Performance Reporting [14 ± 5 days In-Home]

   Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

3. Number of Participants Subjective Performance Rating of the Nasal Mask [14 ± 5 days In-Home]

   Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

4. Number of Participants Subjective Reporting of Nasal Mask Usability [During Visit Two - 20 minutes]

   Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

5. Number of Participants Subjective Recording of Ease of Nasal Mask Use. [14 ± 5 days In-Home]

   Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

Secondary Outcome Measures

1. Number of Participants Leak Compared to Usual Mask [14 ± 5 days In-Home]

   Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

2. Number of Participants With Correct Nasal Mask Size Determination [1 day-time appointment (1 hour)]

   Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 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 nasal or nasal pillows mask users (preferable 70%:30% split)

• 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	Clinical Trials of Florida	South Miami	Florida	United States	33186

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 12, 2017

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT03124069
• Other Study ID Numbers: CIA-211
• First Posted: Apr 21, 2017
• Last Update Posted: Jul 14, 2021
• Last Verified: Jun 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 Nasal 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 nasal mask during this treatment arm.
Period Title: Overall Study
STARTED	37
COMPLETED	37
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	F&P Nasal
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 nasal mask during this treatment arm.
Overall Participants	37
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	37 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	14 37.8%
Male	23 62.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 35.1%
Not Hispanic or Latino	22 59.5%
Unknown or Not Reported	2 5.4%
Region of Enrollment (participants) [Number]
United States	37 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Comfort Compared to Their Usual Mask.
Description	Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Nasal
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 nasal mask during this treatment arm. .
Measure Participants	37
Much better	17 45.9%
Better	4 10.8%
Same	9 24.3%
Worse	6 16.2%
Much Worse	1 2.7%

2. Primary Outcome

Title	Number of Participants PAP Device Performance Reporting
Description	Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Nasal
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 nasal mask during this treatment arm. .
Measure Participants	37
Better than usual mask	9 24.3%
Same as usual mask	13 35.1%
Worse than usual mask	2 5.4%
No data	13 35.1%

3. Primary Outcome

Title	Number of Participants Subjective Performance Rating of the Nasal Mask
Description	Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Nasal
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 nasal mask during this treatment arm.
Measure Participants	37
Very good	23 62.2%
Good	6 16.2%
Acceptable	4 10.8%
Poor	4 10.8%
Very Poor	0 0%

4. Primary Outcome

Title	Number of Participants Subjective Reporting of Nasal Mask Usability
Description	Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time Frame	During Visit Two - 20 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Nasal
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 nasal mask during this treatment arm.
Measure Participants	37
Very Easy	23 62.2%
Easy	9 24.3%
Acceptable	5 13.5%
Difficult	0 0%
Very Difficult	0 0%

5. Primary Outcome

Title	Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Description	Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Nasal 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 nasal mask during this treatment arm.
Measure Participants	37
Very Easy	23 62.2%
Easy	9 24.3%
Acceptable	5 13.5%
Difficult	0 0%
Very Difficult	0 0%

6. Secondary Outcome

Title	Number of Participants Leak Compared to Usual Mask
Description	Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time Frame	14 ± 5 days In-Home

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Nasal
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 nasal mask during this treatment arm. .
Measure Participants	37
No Data	13 35.1%
Better than current mask	9 24.3%
Same as current mask	13 35.1%
Worse than current mask	2 5.4%

7. Secondary Outcome

Title	Number of Participants With Correct Nasal Mask Size Determination
Description	Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Time Frame	1 day-time appointment (1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	F&P Nasal 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 nasal mask during this treatment arm.
Measure Participants	37
Correct	22 59.5%
In between sizes	6 16.2%
Incorrect	9 24.3%

Adverse Events

Time Frame	2 weeks
Arm/Group Title	F&P Nasal 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 nasal mask during this treatment arm.
All Cause Mortality
	F&P Nasal Mask
	Affected / at Risk (%)	# Events
Total	0/37 (0%)
Serious Adverse Events
	F&P Nasal Mask
	Affected / at Risk (%)	# Events
Total	0/37 (0%)
Other (Not Including Serious) Adverse Events
	F&P Nasal Mask
	Affected / at Risk (%)	# Events
Total	0/37 (0%)

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.