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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Snoring
- Sponsor
- Seven Dreamers Europe SAS
- Enrollment
- 32
- Locations
- 6
- Primary Endpoint
- Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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™.
Outcomes
Primary Outcomes
Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
Time Frame: 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
Time Frame: 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 Outcomes
- Observance(1 month)
- Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)(1 month)
- Change from baseline Sleepiness at 1 month(1 month)
- Adverse Events [Safety and Tolerability](1 month)
- Change from baseline Nasal Obstruction at 1 month(1 month)
- Physician satisfaction(1 month)