Back to resultsThe Evaluation of the Toffee 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
Toffee Full Face Mask
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 OSA 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
- Pulmonary Disease Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toffee Full Face Mask
Arm Description
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Outcomes
Primary Outcome Measures
Toffee Mask Acceptability
Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective
Toffee Mask Comfort
Overall Toffee mask comfort determined from questionnaires-Subjective
Toffee Mask Treatment Seal Performance-Subjective
Sealing performance of Toffee mask determined from questionnaires - Subjective
Secondary Outcome Measures
Toffee Mask Treatment Performance-Objective
Objective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective
Full Information
NCT ID
NCT03726346
First Posted
October 28, 2018
Last Updated
May 25, 2022
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03726346
Brief Title
The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
Official Title
The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
November 13, 2019 (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
Device Product Not Approved or Cleared by U.S. FDA
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 of the F&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.
Detailed Description
Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F&P Toffee mask for use in home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two. 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 2 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
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toffee Full Face Mask
Arm Type
Experimental
Arm Description
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Intervention Type
Device
Intervention Name(s)
Toffee Full Face Mask
Intervention Description
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Primary Outcome Measure Information:
Title
Toffee Mask Acceptability
Description
Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective
Time Frame
14±4 days in home
Title
Toffee Mask Comfort
Description
Overall Toffee mask comfort determined from questionnaires-Subjective
Time Frame
14±4 days in home
Title
Toffee Mask Treatment Seal Performance-Subjective
Description
Sealing performance of Toffee mask determined from questionnaires - Subjective
Time Frame
14±4 days in home
Secondary Outcome Measure Information:
Title
Toffee Mask Treatment Performance-Objective
Description
Objective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective
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 OSA 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
Catherine Goodwin
Organizational Affiliation
Research Director
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas O'Brien, MD
Organizational Affiliation
Pulmonologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Disease Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
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