Nasal Airway Stent (Nastent®) Study in OSA

Antwerp University Hospital (UZA)

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Device: Nastent® (a distally perforated soft silicon nasal tube); Diagnostic Test: Polygraphy with WatchPAT™ 300

Study type: Interventional

Funder types: Other

Identifiers

NCT04305964

B300201942080

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Nastent® users

Experimental group

Description:

Patients with an established diagnosis of obstructive sleep apnea with apnea/hypopnea-index (AHI) \< 20/ hour sleep who receive Nastent® as treatment modality

Treatment:

Diagnostic Test: Polygraphy with WatchPAT™ 300

Device: Nastent® (a distally perforated soft silicon nasal tube)