Safety and Performance Study of the Nyxoah SAT System for Treating OSA

Nyxoah

Status: Terminated

Conditions: Obstructive Sleep Apnea

Treatments: Device: Nyxoah SAT system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02312479

SAT2014A

Details and patient eligibility

About

A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea

Enrollment: 6 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with moderate to severe Obstructive Sleep Apnea
• Have failed or have not tolerated CPAP treatment
• Willing and capable of providing informed consent
• Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Exclusion criteria

• BMI limits
• Subjects with complete concentric collapse at the soft palate level per endoscopy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Nyxoah SAT therapy

Experimental group

Treatment:

Device: Nyxoah SAT system