Whitsundays (Nasal) Mask Take Home Study (90 Days)
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT06036329. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
Evaluating the Usability and Performance of a PAP Mask System in the Home Environment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06036329
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2023 (Actual)
- Primary completion
- Nov 6, 2023 (Actual)
- Completion
- Nov 6, 2023 (Actual)
- Last update posted
- Feb 29, 2024
2023
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Data | San Diego | California | 92123 | — |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06036329, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 29, 2024 · Synced Nov 15, 2026
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