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OpenTrials
Completed

NCT Number: NCT03510403

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

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.

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Key information

Conditions

Snoring Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet ORL de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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™.

Treatment and study plan

nastent™

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Seven Dreamers Europe SAS

Industry

Collaborators

  • Slb Pharma
  • nastent.inc

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2018
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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