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

Seven Dreamers Europe

Status: Completed

Conditions: Snoring; Obstructive Sleep Apnea

Treatments: Device: nastent™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03510403

NASTENT-17-FR

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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™.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Device : nasal airway stent

Experimental group

Description:

Patients with OSA or snoring use the nasal airway stent nastent™ each night for sleeping. The device is a tube-shaped medical device that is inserted from the nose and the tip of the tube reaches the soft palate. The inserted tube aids breathing by preventing the obstruction of the airway which causes poor sleep, frequent awakening during sleep and snoring.

Treatment:

Device: nastent™