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Nasal Airway Stent (Nastent®) Study in OSA

NCT04305964 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-07-30

No results posted yet for this study

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). 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.

Conditions

Interventions

DEVICE

Nastent® (a distally perforated soft silicon nasal tube)

Insertion of the Nastent® to nostril during sleep hours

DIAGNOSTIC_TEST

Polygraphy with WatchPAT™ 300

WatchPAT™ 300 is an innovative diagnostic Home Sleep Apnea Test (HSAT) that utilizes the proprietary Peripheral Arterial Tone signal (PAT™) to enable simple, accurate and reliable sleep apnea testing.

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Olivier Vanderveken, MD, PhD · Head of ENT department, UZA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305964 on ClinicalTrials.gov