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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
F&P Saturn
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Trials of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F&P Saturn

Arm 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.

Outcomes

Primary Outcome Measures

Number of Participants Reporting Comfort Compared to Their Usual Mask.
Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants PAP Device Performance Reporting
Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Performance Rating of the Nasal Mask
Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Reporting of Nasal Mask Usability
Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
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

Number of Participants Leak Compared to Usual Mask
Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants With Correct Nasal Mask Size Determination
Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea

Full Information

First Posted
April 11, 2017
Last Updated
June 24, 2021
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03124069
Brief Title
A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Official Title
A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
After a period of baseline, all enrolled participants will be put on the same trial mask.
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F&P Saturn
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
F&P Saturn
Intervention 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.
Primary Outcome Measure Information:
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
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
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
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
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
Secondary Outcome Measure Information:
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
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Trials of Florida
City
South Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared with any other researchers or parties.

Learn more about this trial

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

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