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COMPLETED NA

Whitsundays (Nasal) Mask Take Home Study (90 Days)

NCT06036329 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2023-05-31
Est. Completion 2023-11-06
Phase NA

Sponsor

ResMed

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06036329

The ClinicalTrials.gov registry entry for NCT06036329 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ResMed, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06036329 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06036329?

This trial is sponsored by ResMed, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial