Nasal Airway Stent (Nastent®) Study in OSA

NCT ID: NCT04305964

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-12-31

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.

Detailed 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nastent® users

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

Group Type: EXPERIMENTAL

Nastent® (a distally perforated soft silicon nasal tube)

Intervention Type: DEVICE

Insertion of the Nastent® to nostril during sleep hours

Polygraphy with WatchPAT™ 300

Intervention Type: 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.

Interventions

Nastent® (a distally perforated soft silicon nasal tube)

Insertion of the Nastent® to nostril during sleep hours

Intervention Type: DEVICE

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

PG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

ethisch.comite@uza.be

Prof. Dr. Olivier Vanderveken

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Vanderveken, MD, PhD

Role: STUDY_CHAIR

Head of ENT department, UZA

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 30281824 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25544266 (View on PubMed)

Other Identifiers

B300201942080

Identifier Type: -

Identifier Source: org_study_id