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The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
NCT03242148 · View on ClinicalTrials.gov ↗
Study Summary
This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)
Conditions Studied
Interventions
- DEVICE Toffee Nasal Pillows Mask
Study Locations (1)
Ohio
- Ohio Sleep Medicine Institute — Dublin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-09-16 |
| Est. Completion | 2017-11-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03242148
The ClinicalTrials.gov registry entry for NCT03242148 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 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fisher and Paykel Healthcare, which has 9 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 1 intervention — of which Toffee Nasal Pillows Mask 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: NCT03242148 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. 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 NCT03242148 about?
NCT03242148 is a clinical study titled "The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea". This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Slee...
What is the current status of trial NCT03242148?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2017-09-16. Estimated completion is 2017-11-03.
What conditions does trial NCT03242148 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 NCT03242148?
The interventions under investigation include: Toffee Nasal Pillows Mask (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03242148?
This trial is sponsored by Fisher and Paykel Healthcare, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03242148 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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