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NCT06036329 · ClinicalTrials.gov registry record · NA
Whitsundays (Nasal) Mask Take Home Study (90 Days)
A NA study of Obstructive Sleep Apnea, sponsored by ResMed.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT06036329: Completed NA study of Obstructive Sleep Apnea, sponsored by ResMed.
NCT06036329 is a NA study of Obstructive Sleep Apnea that has completed, run by ResMed. The registered enrollment target is 120 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (46% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06036329, a NA study of Obstructive Sleep Apnea, has completed, sponsored by ResMed.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
• 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.
Conditions Studied
Interventions
- DEVICE Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion
- DEVICE Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
Study Locations (2)
California
- Sleep Data - San Diego
Missouri
- Clayton Sleep Institute - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-05-31 |
| Est. Completion | 2023-11-06 |
| Phase | NA |
What the finished NCT06036329 record still lists
NCT06036329 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion is the first listed.
NCT06036329 reports a single indexed study location in California, Missouri.
Frequently Asked Questions
What is clinical trial NCT06036329 about?
NCT06036329 is a clinical study titled "Whitsundays (Nasal) Mask Take Home Study (90 Days)". 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 current status of trial NCT06036329?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2023-05-31. Estimated completion is 2023-11-06.
What conditions does trial NCT06036329 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT06036329?
The interventions under investigation include: Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion (DEVICE), Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions (DEVICE).
Who is sponsoring clinical trial NCT06036329?
This trial is sponsored by ResMed, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06036329 being conducted?
This trial has 2 study locations across California, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06036329's enrollment target sits among peer trials
120 61st of 155 higher than 92 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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