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

NCT03999944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-06-23

Study results available
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Summary

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

Conditions

Interventions

DEVICE

positive airway pressure system

Positive Airway Pressure System

Sponsors & Collaborators

  • FRESCA Medical

    lead INDUSTRY

Principal Investigators

  • Mark Goetting, MD · Bronson Sleep Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2020-01-07
Completion
2020-01-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999944 on ClinicalTrials.gov