Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
NCT03510403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2019-08-26
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
Interventions
- DEVICE
-
nastent™
Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.
Sponsors & Collaborators
-
Slb Pharma
collaborator OTHER -
nastent.inc
collaborator UNKNOWN -
Seven Dreamers Europe SAS
lead INDUSTRY
Principal Investigators
-
Marc Blumen, MD · Foch Hospital, Suresnes, FRANCE
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-12
- Primary Completion
- 2019-07-25
- Completion
- 2019-07-25
Countries
- France
Study Locations
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