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

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

      • Bordeaux, France, 33000
        • Cabinet ORL de Bordeaux
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Créteil, France, 94010
        • Henri-Mondor Hospital
      • Montpellier, France, 34070
        • Beau-Soleil Private Hospital
      • Paris, France, 75017
        • Centre Médical Veille Sommeil
      • Suresnes, France, 92151
        • Foch Hospital

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

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.
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.
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.
1 month
Change from baseline Nasal Obstruction at 1 month
Time Frame: 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.
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.
1 month
Adverse Events [Safety and Tolerability]
Time Frame: 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.
1 month
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.
1 month
Physician satisfaction
Time Frame: 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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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

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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