Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation (OSPREY)

LivaNova

Status: Active, not recruiting

Conditions: Hypopnea, Sleep; Apnea, Obstructive Sleep; Apnea; Apnea+Hypopnea; Apnea, Obstructive; OSA; Obstructive Sleep Apnea

Treatments: Device: Hypoglossal Nerve Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04950894

LNS005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Active

Active Comparator group

Description:

HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13

Treatment:

Device: Hypoglossal Nerve Stimulation

Control

Other group

Description:

HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13

Treatment:

Device: Hypoglossal Nerve Stimulation