Whitsundays (Nasal) Mask Take Home Study (90 Days)
Evaluating the Usability and Performance of a PAP Mask System in the Home Environment
2 other identifiers
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2023
CompletedFirst Submitted
Initial submission to the registry
July 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2023
CompletedFebruary 29, 2024
July 1, 2023
5 months
July 18, 2023
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
90 days
Secondary Outcomes (8)
11 point Likert Scale Questionnaire
90 days
Apnea Hypopnea Index (AHI)
90 days
Compliance
90 days
Leak
90 days
Pressure Differences
90 days
- +3 more secondary outcomes
Study Arms (2)
Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion
EXPERIMENTAL• Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested)
Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
EXPERIMENTAL• Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Interventions
Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested)
Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (2)
Sleep Data
San Diego, California, 92123, United States
Clayton Sleep Institute
St Louis, Missouri, 63123, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Hevener, RPSGT
Sleep Data
- PRINCIPAL INVESTIGATOR
Matthew Uhles, MS
Clayton Sleep Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2023
First Posted
September 13, 2023
Study Start
May 31, 2023
Primary Completion
November 6, 2023
Study Completion
November 6, 2023
Last Updated
February 29, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share