- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510403
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
August 21, 2019 updated by: Seven Dreamers Europe SAS
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bordeaux, France, 33000
- Cabinet ORL de Bordeaux
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Créteil, France, 94010
- Centre Hospitalier Intercommunal de Créteil
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Créteil, France, 94010
- Henri-Mondor Hospital
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Montpellier, France, 34070
- Beau-Soleil Private Hospital
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Paris, France, 75017
- Centre Médical Veille Sommeil
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Suresnes, France, 92151
- Foch Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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™.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 month
|
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.
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1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Sleepiness at 1 month
Time Frame: 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.
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1 month
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Change from baseline Nasal Obstruction at 1 month
Time Frame: 1 month
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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.
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1 month
|
Observance
Time Frame: 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.
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1 month
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Adverse Events [Safety and Tolerability]
Time Frame: 1 month
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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.
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1 month
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Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time Frame: 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.
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1 month
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Physician satisfaction
Time Frame: 1 month
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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.
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1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc Blumen, MD, Foch Hospital, Suresnes, FRANCE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2018
Primary Completion (Actual)
July 25, 2019
Study Completion (Actual)
July 25, 2019
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 20, 2018
First Posted (Actual)
April 27, 2018
Study Record Updates
Last Update Posted (Actual)
August 26, 2019
Last Update Submitted That Met QC Criteria
August 21, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NASTENT-17-FR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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