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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-12

Study Completion Date

2019-07-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Snoring Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device : nasal airway stent

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.

Group Type EXPERIMENTAL

nastent™

Intervention Type DEVICE

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

Interventions

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nastent™

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

Intervention Type DEVICE

Eligibility Criteria

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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™.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No