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

NCT03510403 | Completed

• 1 other identifier: NASTENT-17-FR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

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.

Conditions

Snoring; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 month

Secondary Outcomes (6)

• Change from baseline Sleepiness at 1 month

  1 month

• Change from baseline Nasal Obstruction at 1 month

  1 month

• Observance

  1 month

• Adverse Events [Safety and Tolerability]

  1 month

• Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  1 month

Study Arms (1)

Device : nasal airway stent

EXPERIMENTAL

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.

Device: nastent™

Interventions

nastent™ DEVICE

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

Device : nasal airway stent

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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™.

Sponsors & Collaborators

• Seven Dreamers Europe SAS: lead
• Slb Pharma: collaborator
• nastent.inc: collaborator

Study Sites (6)

Cabinet ORL de Bordeaux

Bordeaux, 33000, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

Henri-Mondor Hospital

Créteil, 94010, France

Location

Beau-Soleil Private Hospital

Montpellier, 34070, France

Location

Centre Médical Veille Sommeil

Paris, 75017, France

Location

Foch Hospital

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marc Blumen, MD

  Foch Hospital, Suresnes, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 27, 2018
• Study Start: April 12, 2018
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

FR (6)