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Search / Trial NCT04305964

Nasal Airway Stent (Nastent®) Study in OSA

Launched by UNIVERSITY HOSPITAL, ANTWERP · Mar 9, 2020

Trial Information

Current as of May 08, 2025

Unknown status

Keywords

Obstructive Sleep Apnea Snoring Stent

ClinConnect Summary

Patients with an established diagnosis of OSA with apnea/hypopnea-index (AHI)\< 20/ hour sleep from the ENT department are recruited and informed about the study. After obtaining informed consent and patient inclusion, a baseline portable sleep monitoring at home using WatchPAT™300 for one night is performed. During the next visit the objective size and position of the stent is determined under direct visualization using fiberoptic nasolaryngoscopy. Subsequently, the patients will receive a Nastent® Starter kit (containing 6 different stent sizes of Nastent®, 130, 135, 140, 145, 150 and 155...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18
  • AHI ≤ 20 per hour of sleep
  • Complaints of socially disturbing snoring by the partner of the patient
  • Capable of giving informed consent
  • Exclusion Criteria:
  • Craniofacial deformities
  • Acute nasal trauma, fracture (during the past 3 months)
  • Nasal valve collapse, synechiae and septal perforation, recurrent epistaxis, recent nasopharyngeal surgery, chronic rhinosinusitis with or without polyposis
  • Cerebrospinal fluid leaks
  • History of past or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient), intellectual disability, memory disorders, seizure disorders, neuromuscular disorders, cardiovascular diseases, coagulopathies (thrombocytopenia\< 100/µl), lower respiratory tract disorders.
  • Pregnancy or willing to become pregnant
  • Excessive alcohol or drug use (\> 20 alcohol units/week or any use of hard drugs)
  • History of sleep medication use

About University Hospital, Antwerp

University Hospital Antwerp is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital fosters a collaborative environment that integrates cutting-edge scientific inquiry with state-of-the-art medical practices. As a prominent sponsor of clinical trials, University Hospital Antwerp is committed to enhancing medical knowledge and improving treatment outcomes across a wide range of specialties, leveraging its expertise to contribute significantly to the global medical community.

Locations

Edegem, Antwerp, Belgium

Patients applied

0 patients applied

Trial Officials

Olivier Vanderveken, MD, PhD

Study Chair

Head of ENT department, UZA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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