Nasal Airway Stent (Nastent®) Study in OSA
Nasal Airway Stent (Nastent®) Study in OSA
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). Nastent®, a distally perforated soft silicon nasal tube, is a
 mechanical splint against collapse of the upper airway at multiple levels. Nastent® might be
 able to prevent the vibrations caused by fluttering of various parts of the upper airway
 which leads to snoring. Furthermore, it also potentially secures a patent airway throughout
 the night securing airflow.
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 155mm) to gradually get
 accustomed to the stent and to find the right size for them. During the following
 consultation, a Nastent® classic kit (containing 7 stents of the same size, each can be used
 for two consecutive nights) is given to the patients to be used for 14 consecutive nights.
 During the last night of this 14-night period, a follow-up home portable sleep monitoring
 evaluation using WatchPAT™300 is performed with Nastent® in situ. Afterwards, during the
 final visit at the outpatient clinic, acceptance of the therapy with Nastent® by the patients
 is evaluated, and the decision of whether to continue the therapy and to proceed to the
 purchase of this product as a long-term treatment for the patient or not, is made.
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