Nasal Airway Stent (Nastent®) Study in OSA

NCT04305964 | Unknown DMC

• 1 other identifier: B300201942080
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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). 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

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Snoring; Stent

Outcome Measures

Primary Outcomes (2)

• AHI (apnea-hypopnea index)

  Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5\< normal, 5-15 Mild, 15-30 moderate, \<30 severe)

  At baseline

• AHI (apnea-hypopnea index)

  Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5\< normal, 5-15 Mild, 15-30 moderate, \<30 severe)

  at follow up after completion of treatment period (an average of three weeks)

Secondary Outcomes (32)

• Epworth sleepiness scale score (ESS)

  baseline

• VAS (visual analogue scale) for snoring

  Baseline

• ODI (oxygen desaturation index)

  baseline

• PAT (peripheral arterial tone) signal

  baseline

• Heart rate

  baseline

Study Arms (1)

Nastent® users

EXPERIMENTAL

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

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

Interventions

Nastent® (a distally perforated soft silicon nasal tube) DEVICE

Insertion of the Nastent® to nostril during sleep hours

Nastent® users

Polygraphy with WatchPAT™ 300 DIAGNOSTIC_TEST

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.

Also known as: PG

Nastent® users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• AHI ≤ 20 per hour of sleep
• Complaints of socially disturbing snoring by the partner of the patient
• Capable of giving informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (2)

• Okuno K, Ono Minagi H, Ikai K, Matsumura Ai E, Takai E, Fukatsu H, Uchida Y, Sakai T. The efficacy of nasal airway stent (Nastent) on obstructive sleep apnoea and prediction of treatment outcomes. J Oral Rehabil. 2019 Jan;46(1):51-57. doi: 10.1111/joor.12725. Epub 2018 Oct 21.

  PMID: 30281824 BACKGROUND

• Kumar AR, Guilleminault C, Certal V, Li D, Capasso R, Camacho M. Nasopharyngeal airway stenting devices for obstructive sleep apnoea: a systematic review and meta-analysis. J Laryngol Otol. 2015 Jan;129(1):2-10. doi: 10.1017/S0022215114003119. Epub 2014 Dec 29.

  PMID: 25544266 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Vanderveken, MD, PhD

  Head of ENT department, UZA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Olivier Vanderveken

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 12, 2020
• Study Start: May 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)