Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea

Prospective Non-comparative Study to Assess the Efficacy, the Safety and the Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea Syndrome in European Population

This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.

Inclusion Criteria:

• Subject with newly diagnosed OSA (5≤AHI≤30 ev/h) or for whom treatment has failed (CPAP, mandibular repositioning device), or patients with snoring only (5<AHI)
• BMI≤30kg/m²
• Patient with good motivation to use the nasal device,
• Informed consent signed,
• Patient with social protection.

Exclusion Criteria:

• Cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke),
• Respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (COPD),
• Patient with one or more documented contraindication to use Nastent™,
• no regular partner,
• contraindication for sleep endoscopy,
• Psychiatric or neurological disorders (epilepsy),
• Progressive cancer or chronic inflammatory disease,
• AHI including more than 5 central apnea per hour,
• Allergy to one component of Nastent™.