Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

N/AActive Not RecruitingNCT04950894

LivaNova150 enrolled

Overview

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit. The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13) Safety and efficacy will be evaluated at Month 7, and again at Month 13.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Obstructive Sleep Apnea OSA Apnea Apnea, Obstructive Apnea, Obstructive Sleep Apnea+Hypopnea Hypopnea, Sleep

Interventions

Hypoglossal Nerve StimulationDEVICE

Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Abbreviated: Additional criteria may apply: Inclusion Criteria: * Diagnosis of moderate to severe OSA * Declines to use or does not tolerate PAP therapy Exclusion Criteria: * Respiratory, cardiac, renal disease or other co-morbid conditions * BMI \> 35 kg/m2 * Specific PSG criteria outlined in the protocol

Locations (20)

University of Alabama At Birmingham

Birmingham, Alabama, United States

Banner Health

Outcomes

Primary Outcomes

Rate of response to therapy when compared to no therapy for 6 months

The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.

Time frame: Month 1 through Month 7

Rate of all serious adverse device/procedure related events from time of implant through month 7

The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC).

Time frame: Month 1 through Month 7