Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

Nyxoah

Status: Active, not recruiting

Conditions: Obstructive Sleep Apnea

Treatments: Device: Genio™ system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03868618

CL-GEN-002033

Details and patient eligibility

About

A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Enrollment: 115 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) limitations
• Likely suffer from moderate to severe OSA based on history and physical
• Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments
• Willing and capable of providing informed consent

Exclusion criteria

• Inadequately treated sleep disorders other than OSA
• Significant co-morbidities that contraindicates surgery or general anesthesia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Genio Therapy

Experimental group

Description:

The Genio™ system is an implantable neurostimulation system comprised of one implanted device

Treatment:

Device: Genio™ system