The use of nasal airway stent (Nastent R) in patients with sleep-disordered breathing (SDB) including snoring and/or obstructive sleep apnea (OSA).

Withdrawn

Conditions: obstructief slaapapneu
Sleep apnea
Snoring

Registration Number: NL-OMON50116

Lead Sponsor: astent, inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Age > 18
AHI < 20 per hour of sleep
Complaints of socially disturbing snoring by partner
Capable of giving informed consent

Exclusion Criteria

- Craniofacial deformities
- Acute nasal trauma, fracture (during 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)
- Sleep medication use

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assessment of the efficacy of Nastent R in treatment of snoring and/or OSA by<br /><br>use of the RDI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Epworth sleepiness scale score (ESS), Mean SaO2 (SaO2), AHI, ODI (oxygen<br /><br>desaturation index), VAS (visual analogue scale) for snoring as reported by the<br /><br>partner and evaluation of symptoms.</p><br>