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

NCT03999944 | Completed Results FDA Device

• 1 other identifier: 18-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  The mean combined number of apnea and hypopnea events per hour of sleep

  1 sleep night

Secondary Outcomes (1)

• Oxygen Desaturation Index (ODI)

  1 sleep night

Study Arms (2)

Sequence 1

OTHER

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

Sequence 2

OTHER

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

Interventions

positive airway pressure system DEVICE

Positive Airway Pressure System

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• FRESCA Medical: lead

Study Sites (6)

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, 33707, United States

Location

NeuroTrials Research

Atlanta, Georgia, 30342, United States

Location

Neurological Center of North GA

Gainesville, Georgia, 30501, United States

Location

Bronson Sleep Health

Portage, Michigan, 49024, United States

Location

Clinilabs Drug Development Corp

New York, New York, 10019, United States

Location

Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Vice President, RA/CA/QA
• Organization: FRESCA Medical

mlmooney@frescamed.com

949-542-3535

Study Officials

• Mark Goetting, MD

  Bronson Sleep Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Central sleep study scorer will be masked to assignment group
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, randomized crossover assignment, multi-center study conducted in the United States

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: October 14, 2019
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: June 23, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)