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

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: positive airway pressure system

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33707
      • Clinical Research Group of St. Petersburg
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research
    • Gainesville, Georgia, United States, 30501
      • Neurological Center of North GA
  • Michigan
    • Portage, Michigan, United States, 49024
      • Bronson Sleep Health
  • New York
    • New York, New York, United States, 10019
      • CLINILABS Drug Development Corp
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence 1; FRESCA Airbox Flow Generator set to fixed pressure first, then FRESCA Airbox Generator set to auto-adjusting pressure. Second intervention within 1 - 10 days of first intervention.	Device: positive airway pressure system; Positive Airway Pressure System
Other: Sequence 2; FRESCA Airbox Flow Generator set to auto-adjusting pressure first, then FRESCA Airbox Generator set to fixed pressure. Second intervention within 1 - 10 days of first intervention.	Device: positive airway pressure system; Positive Airway Pressure System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index (AHI)	The mean combined number of apnea and hypopnea events per hour of sleep	1 sleep night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Desaturation Index (ODI)	The number of oxygen desaturations ≥ 4% per hour of sleep	1 sleep night

Collaborators and Investigators

• Sponsor: FRESCA Medical
• Investigators: Principal Investigator: Mark Goetting, MD, Bronson Sleep Health

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: 18-01 (National Center for Advancing Translational Sciences (NCATS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No