Clinical trial NCT06036329: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: 11 point Likert Scale Questionnaire
timeFrame: 90 days
Secondary outcomes:
measure: 11 point Likert Scale Questionnaire
timeFrame: 90 days
measure: Apnea Hypopnea Index (AHI)
timeFrame: 90 days
measure: Compliance
timeFrame: 90 days
measure: Leak
timeFrame: 90 days
measure: Pressure Differences
timeFrame: 90 days
measure: Frequency of Cushion Replacement
timeFrame: 90 days
measure: Reason for Cushion Replacement
timeFrame: 90 days
measure: Deterioration of Mask
timeFrame: 90 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sleep Data
state: California
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
affiliation: Sleep Data
name: William Hevener, RPSGT
role: PRINCIPAL_INVESTIGATOR
affiliation: Clayton Sleep Institute
name: Matthew Uhles, MS
role: PRINCIPAL_INVESTIGATOR
References: