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The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

NCT03242148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-09-22

Study results available
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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

Interventions

DEVICE

Toffee Nasal Pillows Mask

Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.

Sponsors & Collaborators

  • Aspen Clinical Research

    collaborator OTHER

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • Asim Roy · Board Certified Sleep Specialist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-16
Primary Completion
2017-11-03
Completion
2017-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242148 on ClinicalTrials.gov