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

Completed · Not applicable

Conditions studied: Sleep Apnea

In brief

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

Key facts

Study ID

NCT03999944

Run by

FRESCA Medical

People needed

52

Starts

2019-10-14

Expected to finish

2020-01-07

Last updated by the study team

2021-06-23

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
• Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
• Subjects with prior surgical intervention for OSA.
• Subjects with frequent or sustained episodes of O2 saturation ≤75%.
• Subjects with obesity-related hypoventilation.
• Subjects currently using a CPAP full face mask.
• Subjects who are medically unstable.
• Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease).
• Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication.
• Subjects with hypotension or uncontrolled HTN.
• Subjects with chronic lung disease, including COPD.
• Subjects with significant cardiopulmonary disease.
• Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask.
• Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year.
• Subjects currently working nights, rotating night shifts or with planned travel during the study period.
• Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
• Subjects who consume > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee).
• Subjects who consume > 14 alcoholic drinks/week.
• Subjects who are pregnant (confirmed verbally).
• Subjects currently enrolled in any other research study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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