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Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System | Clinical Trials | Clareo Health

COMPLETEDNA

Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System

Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System Versus the (Predicate) FRESCA Positive Airway Pressure System for the Treatment of Obstructive Sleep Apnea

NCT03999944•FRESCA Medical

View on ClinicalTrials.gov

Summary

Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States

Detailed Description

This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.

Eligibility

Age

22 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female aged 22 - 75 years old.
•2. BMI: ≤ 40 kg/m2.
•3. Subjects diagnosed with OSA (either newly diagnosed (naive) OSA subjects or current CPAP subjects).
•4. Must be able to be fitted properly with FRESCA mask.
•5. Must be able to comply with all study requirements as outlined in the protocol.
•6. Subject must complete a valid PSG titration night.

Exclusion Criteria

•1. Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
•2. Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
•3. Subjects with prior surgical intervention for OSA.
•4. Subjects with frequent or sustained episodes of O2 saturation ≤75%.
•5. Subjects with obesity-related hypoventilation.
•6. Subjects currently using a CPAP full face mask.
•7. Subjects who are medically unstable.
•8. Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease).
•9. Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication.
•10. Subjects with hypotension or uncontrolled HTN.
+10 more criteria

Locations (6)

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, United States

NeuroTrials Research

Atlanta, Georgia, United States

Neurological Center of North GA

Gainesville, Georgia, United States

Bronson Sleep Health

Portage, Michigan, United States

Clinilabs Drug Development Corp

New York, New York, United States

Bogan Sleep Consultants

Columbia, South Carolina, United States

Key Dates

Start Date

October 14, 2019

Primary Completion Date

January 7, 2020

Completion Date

January 7, 2020

Last Updated

June 23, 2021

Enrollment

ACTUAL participants

Conditions

Sleep Apnea

Interventions

positive airway pressure system

DEVICE

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

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RECRUITINGNA

Digital-supported Orofacial Myofunctional Therapy in OSA

NCT07292922

Obstructive Sleep Apnea (OSA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness

A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea