Back to resultsThe Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
Toffee full face mask with 'Improved Seal'
Toffee full face mask with 'Normal Seal'
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 F&P full face 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
- Clinical Trials of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Outcomes
Primary Outcome Measures
Trial Mask Seal Comfort
Overall seal comfort determined from questionnaires- Subjective
Trial Mask Seal Acceptability
Preference for trial mask determined from questionnaires at the end of the trial - Subjective
Secondary Outcome Measures
Trial Mask Seal Treatment Performance - Objective
Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data
Trial Mask Seal Usability
Usability interview during first visit- Subjective
Trial Mask Seal Treatment Performance- Subjective
Seal performance determined from questionnaires - Subjective
Full Information
NCT ID
NCT03230877
First Posted
July 24, 2017
Last Updated
August 15, 2022
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03230877
Brief Title
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Official Title
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site
Detailed Description
This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.
The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.
Visit Three will involve the participants returning the second trial seal and providing feedback.
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
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Intervention Type
Device
Intervention Name(s)
Toffee full face mask with 'Improved Seal'
Intervention Description
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
Intervention Type
Device
Intervention Name(s)
Toffee full face mask with 'Normal Seal'
Intervention Description
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
Primary Outcome Measure Information:
Title
Trial Mask Seal Comfort
Description
Overall seal comfort determined from questionnaires- Subjective
Time Frame
7 ± 4 days in-home
Title
Trial Mask Seal Acceptability
Description
Preference for trial mask determined from questionnaires at the end of the trial - Subjective
Time Frame
14 ± 4 days in-home
Secondary Outcome Measure Information:
Title
Trial Mask Seal Treatment Performance - Objective
Description
Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data
Time Frame
7 ± 4 days in-home
Title
Trial Mask Seal Usability
Description
Usability interview during first visit- Subjective
Time Frame
1 hour day-time appointment
Title
Trial Mask Seal Treatment Performance- Subjective
Description
Seal performance determined from questionnaires - Subjective
Time Frame
7 ± 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 F&P full face 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.
Facility Information:
Facility Name
Clinical Trials of Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This investigation is 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 Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
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