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

Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999944
• Other study ID #: 18-01
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: January 7, 2020

Study information

• Verified date: June 2021
• Source: FRESCA Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• positive airway pressure system
Positive Airway Pressure System

Locations

Country	Name	City	State
United States	NeuroTrials Research	Atlanta	Georgia
United States	Bogan Sleep Consultants	Columbia	South Carolina
United States	Neurological Center of North GA	Gainesville	Georgia
United States	Clinilabs Drug Development Corp	New York	New York
United States	Bronson Sleep Health	Portage	Michigan
United States	Clinical Research Group of St. Petersburg	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
FRESCA Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index (AHI)	The mean combined number of apnea and hypopnea events per hour of sleep	1 sleep night
Secondary	Oxygen Desaturation Index (ODI)	The number of oxygen desaturations = 4% per hour of sleep	1 sleep night