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NCT05573763 · ClinicalTrials.gov registry record · NA
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
A NA study of Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05573763: Completed NA study of Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare.
NCT05573763 is a NA study of Obstructive Sleep Apnea that has completed, run by Fisher and Paykel Healthcare. The registered enrollment target is 40 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05573763, a NA study of Obstructive Sleep Apnea, has completed, sponsored by Fisher and Paykel Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.
Primary Outcome
Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe"
Conditions Studied
Interventions
- DEVICE F&P Toffee
Study Locations (1)
Ohio
- Ohio Sleep Medicine Institute - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-11-14 |
| Est. Completion | 2023-06-16 |
| Phase | NA |
What the finished NCT05573763 record still lists
NCT05573763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which F&P Toffee is the first listed.
NCT05573763 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05573763 about?
NCT05573763 is a clinical study titled "Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022". The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.
What is the current status of trial NCT05573763?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-11-14. Estimated completion is 2023-06-16.
What conditions does trial NCT05573763 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT05573763?
The interventions under investigation include: F&P Toffee (DEVICE).
Who is sponsoring clinical trial NCT05573763?
This trial is sponsored by Fisher and Paykel Healthcare, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05573763 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05573763's enrollment target sits among peer trials
40 112th of 155 higher than 39 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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