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

Seven Dreamers Europe SAS32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Snoring Obstructive Sleep Apnea

Interventions

nastent™DEVICE

Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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™.

Locations (6)

Cabinet ORL de Bordeaux

Bordeaux, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Henri-Mondor Hospital

Créteil, France

Beau-Soleil Private Hospital

Montpellier, France

Outcomes

Primary Outcomes

Efficacy : change from baseline Snoring Intensity at 1 month

The snoring intensity will be evaluated by bed-partner of snorers and OSA patients using a Visual Analogue Scale (0-100 mm) at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.

Time frame: 1 month

Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month

The Apnea Hypopnea Index (number of apnea and hypopnea per hour) will be measured by respiratory polygraph on OSA patients subgroup at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.

Time frame: 1 month

Secondary Outcomes

Change from baseline Sleepiness at 1 month

The Epworth Sleepiness Scale (ESS) will be completed by OSA patients at baseline and after 1 month of nastent™ use to assess the evolution of somnolence/daytime sleepiness. Total score ranges between 0 and 24. A score above 10 indicates excessive daytime sleepiness.

Time frame: 1 month

Change from baseline Nasal Obstruction at 1 month

The NOSE questionnaire will be completed by snorers and OSA patients at baseline and after 1 month of nastent™ use to assess the efficacy of the device on the nasal obstruction.Total score ranges between 0 and 100.

Time frame: 1 month

Observance

The number of hours of Nastent™ use per night, the number of nights per week will be measured to assess the observance and compliance of the treatment in snorers and OSA patients during one month.

Time frame: 1 month

Adverse Events [Safety and Tolerability]

Adverse events reported by patient on a diary (from day 1 to day 30) and clinically observed by the physician will assess the safety and tolerability of the device.

Data from ClinicalTrials.gov

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