BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)

Nyxoah

Status: Completed

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Device: Genio(TM) bilateral hypoglossal nerve stimulation system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03048604

BLAST OSA

Details and patient eligibility

About

The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

Enrollment: 27 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Body mass index ≤32 kg/m2
• Patients who do not tolerate or do not accept positive airway pressure (PAP) treatments.
• Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour

Main Exclusion Criteria:

• Unable or incapable of providing informed written consent
• Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
• Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Genio(TM) system therapy

Experimental group

Treatment:

Device: Genio(TM) bilateral hypoglossal nerve stimulation system