Back to resultsThe Evaluation of a 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 Seal Improvement Project
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Adult (22+ years of age)
- Able to give informed consent
- Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
- Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
- Fluent in spoken and written English
- Existing oronasal and nasal mask user
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 carbon Dioxide (CO2) retention
- Pregnant or may think they are pregnant.
Sites / Locations
- North texas Lung and Sleep Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F&P Seal Improvement Project
Arm Description
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
Outcomes
Primary Outcome Measures
Number of Participants Subjective Usability Reporting
Usability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Number or Participants Comparative Subjective Reported Comfort
Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea compared to usual
Secondary Outcome Measures
Objective Performance Reporting
Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Number of Participants Reported Mask Acceptability
Acceptability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Comfort Reporting
Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Number or Participants Subjective Reporting of Seal Performance
Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Full Information
NCT ID
NCT03142438
First Posted
April 23, 2017
Last Updated
June 24, 2021
Sponsor
Fisher and Paykel Healthcare
Collaborators
North Texas Lung & Sleep Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03142438
Brief Title
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
Official Title
The Evaluation of a Full Face and 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
May 30, 2017 (Actual)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
June 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
Collaborators
North Texas Lung & Sleep Clinic
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 a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database
Detailed Description
Visit 1 will involve the participants being fitted with the F&P trial full face or nasal mask for use in-home.
The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within three weeks of the beginning of 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
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F&P Seal Improvement Project
Arm Type
Experimental
Arm Description
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
Intervention Type
Device
Intervention Name(s)
F&P Seal Improvement Project
Intervention Description
Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
Primary Outcome Measure Information:
Title
Number of Participants Subjective Usability Reporting
Description
Usability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Time Frame
14 ± 4 days in-Home
Title
Number or Participants Comparative Subjective Reported Comfort
Description
Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea compared to usual
Time Frame
14 ± 4 days in-Home
Secondary Outcome Measure Information:
Title
Objective Performance Reporting
Description
Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Time Frame
14 ± 4 days in-Home
Title
Number of Participants Reported Mask Acceptability
Description
Acceptability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Time Frame
14 ± 4 days in-Home
Title
Number of Participants Subjective Comfort Reporting
Description
Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Time Frame
14 ± 4 days in-Home
Title
Number or Participants Subjective Reporting of Seal Performance
Description
Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Time Frame
14 ± 4 days in-Home
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (22+ years of age)
Able to give informed consent
Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
Fluent in spoken and written English
Existing oronasal and nasal mask user
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 carbon Dioxide (CO2) retention
Pregnant or may think they are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ostransky, MD
Organizational Affiliation
Board Certified Sleep Specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
North texas Lung and Sleep Clinic
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Investigation to inform product development team. Results will inform product development on the future of the product.
Learn more about this trial
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
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