Back to resultsWhitsundays (Nasal) Mask Take Home Study (90 Days)
Primary Purpose
Obstructive Sleep Apnea
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion
Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria: Patients willing to give written informed consent Patients who can read and comprehend English Patients who ≥ 18 years of age Patients being treated for OSA with a PAP device for ≥ 6 months Patients currently using a ResMed PAP device (S9, AirSense 10 & AirSense 11) compatible with AirView (with cellular data connectivity and has been sending device data to the cloud) Patients currently using ResMed AirFit N30i or Philips DreamWear™ Nasal Patients who are willing to try the prototype mask for up to 90 nights Patients who are willing to take photos of the prototype mask every 2 weeks for the duration of the study Patients who reside in the USA and intend to stay in the USA for the next 6 months Patients with access to the internet (such as a smartphone or laptop) to complete online surveys Exclusion Criteria: Patients using Bilevel flow generators Patients who are or may be pregnant Patients with a preexisting lung disease/condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury. If you are pregnant or planning to become pregnant Patients believed to be unsuitable for inclusion by the researcher
Sites / Locations
- Sleep Data
- Clayton Sleep Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion
Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Arm Description
• Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested)
• Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Outcomes
Primary Outcome Measures
11 point Likert Scale Questionnaire
• Subjective scores will be collected from subjects on each attribute being assessed (e.g. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Secondary Outcome Measures
11 point Likert Scale Questionnaire
• Subject's subjective impression and comments comparing the prototype mask (Whitsundays Nasal) to the subject's current mask with regards to ease of use, visual appearance, seal, comfort, facial markings, noise and overall performance. • Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Apnea Hypopnea Index (AHI)
• The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Whitsundays mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Compliance
• The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Whitsundays mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Leak
The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Whitsundays mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.
Pressure Differences
The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Whitsundays mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Frequency of Cushion Replacement
• Subject's frequency of cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
Reason for Cushion Replacement
• Subject's reason for cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
Deterioration of Mask
• Photos of the subject's prototype mask system taken at 2-week intervals to observe any visual deterioration such as cracking, crazing, tears, dirt or stain build up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06036329
Brief Title
Whitsundays (Nasal) Mask Take Home Study (90 Days)
Official Title
Evaluating the Usability and Performance of a PAP Mask System in the Home Environment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
November 17, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea. The main questions it aims to answer are:
How the Whitsundays masks performs in the home environment
What is the subject's first impression of the Whitsundays mask and what is their preference compared to their own mask
What is the difference between the subject's objective therapy data when using the Whitsundays mask compared to their own mask
Is there wear and tear of the Whitsundays mask and how frequently do the cushions need replacement Participants will be asked to use the Whitsundays mask for 90 days, answer questionnaires about the initial impression of the mask, the performance of the mask, and their preference compared to their own mask. Researchers will compare one group of subjects who will be provided with cushion replacements to another group who will only be provided with cushion replacements upon request to determine the need for cushion replacement, its frequency, and the reasons for cushion replacement during home usage.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion
Arm Type
Experimental
Arm Description
• Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested)
Arm Title
Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Arm Type
Experimental
Arm Description
• Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Intervention Type
Device
Intervention Name(s)
Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion
Intervention Description
Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested)
Intervention Type
Device
Intervention Name(s)
Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Intervention Description
Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Primary Outcome Measure Information:
Title
11 point Likert Scale Questionnaire
Description
• Subjective scores will be collected from subjects on each attribute being assessed (e.g. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
11 point Likert Scale Questionnaire
Description
• Subject's subjective impression and comments comparing the prototype mask (Whitsundays Nasal) to the subject's current mask with regards to ease of use, visual appearance, seal, comfort, facial markings, noise and overall performance. • Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Time Frame
90 days
Title
Apnea Hypopnea Index (AHI)
Description
• The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Whitsundays mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Time Frame
90 days
Title
Compliance
Description
• The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Whitsundays mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Time Frame
90 days
Title
Leak
Description
The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Whitsundays mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.
Time Frame
90 days
Title
Pressure Differences
Description
The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Whitsundays mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Time Frame
90 days
Title
Frequency of Cushion Replacement
Description
• Subject's frequency of cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
Time Frame
90 days
Title
Reason for Cushion Replacement
Description
• Subject's reason for cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
Time Frame
90 days
Title
Deterioration of Mask
Description
• Photos of the subject's prototype mask system taken at 2-week intervals to observe any visual deterioration such as cracking, crazing, tears, dirt or stain build up
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients willing to give written informed consent
Patients who can read and comprehend English
Patients who ≥ 18 years of age
Patients being treated for OSA with a PAP device for ≥ 6 months
Patients currently using a ResMed PAP device (S9, AirSense 10 & AirSense 11) compatible with AirView (with cellular data connectivity and has been sending device data to the cloud)
Patients currently using ResMed AirFit N30i or Philips DreamWear™ Nasal
Patients who are willing to try the prototype mask for up to 90 nights
Patients who are willing to take photos of the prototype mask every 2 weeks for the duration of the study
Patients who reside in the USA and intend to stay in the USA for the next 6 months
Patients with access to the internet (such as a smartphone or laptop) to complete online surveys
Exclusion Criteria:
Patients using Bilevel flow generators
Patients who are or may be pregnant
Patients with a preexisting lung disease/condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
If you are pregnant or planning to become pregnant
Patients believed to be unsuitable for inclusion by the researcher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Hevener, RPSGT
Organizational Affiliation
Sleep Data
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Uhles, MS
Organizational Affiliation
Clayton Sleep Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Data
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Whitsundays (Nasal) Mask Take Home Study (90 Days)
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