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NCT06060717 · ClinicalTrials.gov registry record · NA
Evaluation of the F&P Caramel Nasal Mask, US, 2023
A NA study, sponsored by Fisher and Paykel Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT06060717: Completed NA study, sponsored by Fisher and Paykel Healthcare.
NCT06060717 is a NA study that has completed, run by Fisher and Paykel Healthcare. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06060717, a NA study, has completed, sponsored by Fisher and Paykel Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal 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 AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep
Interventions
- DEVICE F&P Caramel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2024-06-11 |
| Phase | NA |
What the finished NCT06060717 record still lists
NCT06060717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which F&P Caramel is the first listed.
NCT06060717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06060717 about?
NCT06060717 is a clinical study titled "Evaluation of the F&P Caramel Nasal Mask, US, 2023". The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.
What is the current status of trial NCT06060717?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2023-11-27. Estimated completion is 2024-06-11.
What interventions are being tested in trial NCT06060717?
The interventions under investigation include: F&P Caramel (DEVICE).
Who is sponsoring clinical trial NCT06060717?
This trial is sponsored by Fisher and Paykel Healthcare, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06060717's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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