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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510403
• Other study ID #: NASTENT-17-FR
• Status: Completed
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: July 25, 2019

Study information

• Verified date: August 2019
• Source: Seven Dreamers Europe SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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™.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Seven Dreamers Europe SAS	nastent.inc, Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)	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.	1 month
Secondary	Physician satisfaction	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.	1 month