Status:
UNKNOWN
Nasal Airway Stent (Nastent®) Study in OSA
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study intends to assess the effect of nasal airway stent (Nasten®) as a treatment modality in patients with sleep-disordered breathing (SDB) including snoring and/or obstructive sleep apnea (OSA)...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04305964
Start Date
May 1 2020
End Date
December 1 2021
Last Update
July 30 2021
Active Locations (1)
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1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650