Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

(AERO Trial)

Recruiting at16 trial locations

Overseen by Richard B Berry, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ventus Medical, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) Secondary Endpoints: By polysomnography, reduction in: * AHI with device on vs. off at 3 months, controlling for sleep position * Oxygen desaturation index with device on vs. off * Arousal index with device on vs. off * Duration of snoring with device on vs. off * Epworth Sleepiness Scale Patient acceptance, in terms of: * Refusal rate at screening * Discontinuation rate during follow-up * Daily compliance rate * Device-related adverse events * Serious adverse events

Research Team

Richard B Berry, M.D.

Principal Investigator

University of Florida

Connie A Rey

Principal Investigator

Ventus Medical

Eligibility Criteria

Inclusion Criteria

Age > 18 years

Diagnosis of OSA

AHI > 10 on diagnostic PSG performed within last 3 months

Treatment Details

Interventions

• Provent Professional Sleep Apnea Therapy Device (Positive Airway Pressure Device)
• Sham Device (Procedure)

Participant Groups

Group I: Provent Active Control 1 Intervention

Those receiving the active device

Group II: Sham Placebo Group 1 Intervention

Those receiving sham device

Who Is Running the Clinical Trial?

Ventus Medical, Inc.

Lead Sponsor

Trials

4

Recruited

380+