Clinical trial NCT03999944: Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: FRESCA Medical
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 52
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, open-label, randomized crossover assignment, multi-center study conducted in the United States
Primary purpose: TREATMENT

Brief 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 criteria: 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.
11. Subjects with chronic lung disease, including COPD.
12. Subjects with significant cardiopulmonary disease.
13. 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.
14. Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year.
15. Subjects currently working nights, rotating night shifts or with planned travel during the study period.
16. Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
17. Subjects who consume \> 500 mg caffeine per day (e.g., \> 8 cola-type beverages, \> 5 cups of coffee).
18. Subjects who consume \> 14 alcoholic drinks/week.
19. Subjects who are pregnant (confirmed verbally).
20. Subjects currently enrolled in any other research study.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 1 sleep night
Secondary outcomes:
measure: Oxygen Desaturation Index (ODI)
timeFrame: 1 sleep night
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research
state: Georgia
city: Gainesville
country: United States
facility: Neurological Center of North GA
state: Georgia
city: Portage
country: United States
facility: Bronson Sleep Health
state: Michigan
city: New York
country: United States
facility: Clinilabs Drug Development Corp
state: New York
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
Study officials:
affiliation: Bronson Sleep Health
name: Mark Goetting, MD
role: PRINCIPAL_INVESTIGATOR
References: