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

S

Seven Dreamers Europe

Status

Completed

Conditions

Snoring
Obstructive Sleep Apnea

Treatments

Device: nastent™

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03510403
NASTENT-17-FR

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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™.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Device : nasal airway stent
Experimental group
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.
Treatment:
Device: nastent™

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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