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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 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.

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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.

Conditions Studied

Obstructive Sleep Apnea

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

25 total trials

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What the Registry Record Tells You About NCT06036329

The ClinicalTrials.gov registry entry for NCT06036329 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (46% lower). The listed sponsor is ResMed, which has 25 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.