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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Snoring
• Interventions: Device: nastent™

• Registration Number: NCT03510403
• Lead Sponsor: Seven Dreamers Europe SAS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-03
• Study Start: 2018-04-12
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-04-27
• Primary Completion: 2019-07-25
• Study Completion: 2019-07-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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™.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device : nasal airway stent	nastent™	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.

Primary Outcome Measures

Name	Time	Method
Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month	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.
Efficacy : change from baseline Snoring Intensity at 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Observance	1 month	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.
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)	1 month	FOSQ-10 measures functional status and difficulty in performing everyday activities via 10 questions. The questionnaire will be completed by snorer and OSA patients at baseline and after 1 month of nastent™ use to assess the evolution of the quality of life. Total score ranges between 5 and 20. Higher scores indicate better functional status.
Change from baseline Sleepiness at 1 month	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.
Adverse Events [Safety and Tolerability]	1 month	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.
Change from baseline Nasal Obstruction at 1 month	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.
Physician satisfaction	1 month	The physician's global satisfaction with nastent™ efficacy and safety will be assessed for each patient using a numeric scale after one month of treatment. Score ranges between 0 and 10.

Trial Locations

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

Centre Médical Veille Sommeil; 🇫🇷 Paris, France

Foch Hospital; 🇫🇷 Suresnes, France