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

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

positive airway pressure system

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Clinical Research Group of St. Petersburg
NeuroTrials Research
Neurological Center of North GA
Bronson Sleep Health
Clinilabs Drug Development Corp
Bogan Sleep Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Sequence 1

Sequence 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index (AHI)

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

Secondary Outcome Measures

Oxygen Desaturation Index (ODI)

The number of oxygen desaturations ≥ 4% per hour of sleep

Full Information

NCT ID

NCT03999944

First Posted

June 25, 2019

Last Updated

June 1, 2021

Sponsor

FRESCA Medical

1. Study Identification

Unique Protocol Identification Number

NCT03999944

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

October 14, 2019 (Actual)

Primary Completion Date

January 7, 2020 (Actual)

Study Completion Date

January 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FRESCA Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

Central sleep study scorer will be masked to assignment group

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Other

Arm Description

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.

Arm Title

Sequence 2

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

positive airway pressure system

Intervention Description

Positive Airway Pressure System

Primary Outcome Measure Information:

Title

Apnea-Hypopnea Index (AHI)

Description

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

Time Frame

1 sleep night

Secondary Outcome Measure Information:

Title

Oxygen Desaturation Index (ODI)

Description

The number of oxygen desaturations ≥ 4% per hour of sleep

Time Frame

1 sleep night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Goetting, MD

Organizational Affiliation

Bronson Sleep Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Group of St. Petersburg

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33707

Country

United States

Facility Name

NeuroTrials Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Neurological Center of North GA

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Bronson Sleep Health

City

Portage

State/Province

Michigan

ZIP/Postal Code

49024

Country

United States

Facility Name

Clinilabs Drug Development Corp

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Bogan Sleep Consultants

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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