Obstructive Sleep Apnea, Snoring
Conditions
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.
Interventions
DEVICEnastent™
Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.
Sponsors
Slb Pharma
nastent.inc
Seven Dreamers Europe SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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™.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| 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 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. |
Countries
France
Outcome results
None listed