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Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea

Primary Purpose

Snoring, Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nastent™
Sponsored by
Seven Dreamers Europe SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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™.

Sites / Locations

  • Cabinet ORL de Bordeaux
  • Centre Hospitalier Intercommunal de Créteil
  • Henri-Mondor Hospital
  • Beau-Soleil Private Hospital
  • Centre Médical Veille Sommeil
  • Foch Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device : nasal airway stent

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy : change from baseline Snoring Intensity at 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
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 Outcome Measures

Change from baseline Sleepiness at 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.
Change from baseline Nasal Obstruction at 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.
Observance
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]
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.
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
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.
Physician satisfaction
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.

Full Information

First Posted
April 3, 2018
Last Updated
August 21, 2019
Sponsor
Seven Dreamers Europe SAS
Collaborators
Slb Pharma, nastent.inc
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1. Study Identification

Unique Protocol Identification Number
NCT03510403
Brief Title
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
July 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seven Dreamers Europe SAS
Collaborators
Slb Pharma, nastent.inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device : nasal airway stent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
nastent™
Intervention Description
Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.
Primary Outcome Measure Information:
Title
Efficacy : change from baseline Snoring Intensity at 1 month
Description
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.
Time Frame
1 month
Title
Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change from baseline Sleepiness at 1 month
Description
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.
Time Frame
1 month
Title
Change from baseline Nasal Obstruction at 1 month
Description
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.
Time Frame
1 month
Title
Observance
Description
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.
Time Frame
1 month
Title
Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
1 month
Title
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Description
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.
Time Frame
1 month
Title
Physician satisfaction
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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™.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Blumen, MD
Organizational Affiliation
Foch Hospital, Suresnes, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet ORL de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Henri-Mondor Hospital
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Beau-Soleil Private Hospital
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Centre Médical Veille Sommeil
City
Paris
ZIP/Postal Code
75017
Country
France
Facility Name
Foch Hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

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Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea

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