Nasal Airway Stent (Nastent®) Study in OSA (Nastent)

The Use of Nasal Airway Stent (Nastent®) in Patients With Sleep-disordered Breathing (SDB) Including Snoring and/or Obstructive Sleep Apnea (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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Nastent® (a distally perforated soft silicon nasal tube); Diagnostic test: Polygraphy with WatchPAT™ 300

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: PG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth sleepiness scale score (ESS)	an 8-item questionnaire which takes about three minutes to fill out. It reflects the chance of each person's general level of sleepiness during eight situations of daily life. The subject selects the most appropriate integer score ranging from 0 (would never doze) to 3 (high chance of dozing) for each of the 8 questions. The results are then summed up, with 0 being the minimal and 24 the maximum total ESS score. The higher the ESS score, the higher that person's average sleep propensity in daily life. (0-5=Lower Normal Daytime Sleepiness, 6-10 = Higher Normal Daytime Sleepiness, 11-12 = Mild Excessive Daytime Sleepiness, 13-15 = Moderate Excessive Daytime Sleepiness, 16-24 =Severe Excessive Daytime Sleepiness.)	baseline
VAS (visual analogue scale) for snoring	A standard 10-point VAS ranging from 0 (no snoring) to 10 (extreme snoring causing the bed partner to leave the bedroom or sleep separately) will be used to evaluate the subjective status of snoring during sleep. Heavy snoring corresponds to a snoring index of at least 7. A decrease of 3 points after treatment is considered significant. A satisfactory improvements is defined as a reduction to an index that is no longer experiences as bothersome (i.e. <3).	Baseline
ODI (oxygen desaturation index)	The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.	baseline
PAT (peripheral arterial tone) signal	PAT™ technology is a non-invasive window to the cardiovascular system and autonomic nervous system. Peripheral Arterial Tone (PAT™) signal is a proprietary technology used for non-invasively measuring arterial tone changes in peripheral arterial beds.	baseline
Heart rate	The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.	baseline
Body position	Percentage of supine, prone, left, right, upright position	baseline
Snoring	Snoring loudness in decibels	baseline
Oxygen saturation (SaO2)	A measurement of the percentage of how much hemoglobin is saturated with oxygen	baseline
RDI (Respiratory disturbance index)	Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea	baseline
Sleep/wake state	Percentage of sleep and wake state	baseline
REM sleep	Percentage of REM sleep	baseline
Deep sleep	Percentage of deep sleep	baseline
Light sleep	Percentage of light sleep	baseline
Sleep latency	Latency of start of sleep in minutes	baseline
REM latency	Latency of start of REM sleep in minutes	baseline
Total sleep time	Total sleep time in minutes	baseline
Epworth sleepiness scale score (ESS)	an 8-item questionnaire which takes about three minutes to fill out. It reflects the chance of each person's general level of sleepiness during eight situations of daily life. The subject selects the most appropriate integer score ranging from 0 (would never doze) to 3 (high chance of dozing) for each of the 8 questions. The results are then summed up, with 0 being the minimal and 24 the maximum total ESS score. The higher the ESS score, the higher that person's average sleep propensity in daily life. (0-5=Lower Normal Daytime Sleepiness, 6-10 = Higher Normal Daytime Sleepiness, 11-12 = Mild Excessive Daytime Sleepiness, 13-15 = Moderate Excessive Daytime Sleepiness, 16-24 =Severe Excessive Daytime Sleepiness.)	at follow up after completion of treatment period (an average of three weeks)
VAS (visual analogue scale) for snoring	A standard 10-point VAS ranging from 0 (no snoring) to 10 (extreme snoring causing the bed partner to leave the bedroom or sleep separately) will be used to evaluate the subjective status of snoring during sleep. Heavy snoring corresponds to a snoring index of at least 7. A decrease of 3 points after treatment is considered significant. A satisfactory improvements is defined as a reduction to an index that is no longer experiences as bothersome (i.e. <3).	at follow up after completion of treatment period (an average of three weeks)
ODI (oxygen desaturation index)	The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.	at follow up after completion of treatment period (an average of three weeks)
PAT (peripheral arterial tone) signal	PAT™ technology is a non-invasive window to the cardiovascular system and autonomic nervous system. Peripheral Arterial Tone (PAT™) signal is a proprietary technology used for non-invasively measuring arterial tone changes in peripheral arterial beds.	at follow up after completion of treatment period (an average of three weeks)
Heart rate	The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.	at follow up after completion of treatment period (an average of three weeks)
Body position	Percentage of supine, prone, left, right, upright position	at follow up after completion of treatment period (an average of three weeks)
Snoring	Snoring loudness in decibels	at follow up after completion of treatment period (an average of three weeks)
Oxygen saturation (SaO2)	A measurement of the percentage of how much hemoglobin is saturated with oxygen	at follow up after completion of treatment period (an average of three weeks)
RDI (Respiratory disturbance index)	Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea	at follow up after completion of treatment period (an average of three weeks)
Sleep/wake state	Percentage of sleep and wake state	at follow up after completion of treatment period (an average of three weeks)
REM sleep	Percentage of REM sleep	at follow up after completion of treatment period (an average of three weeks)
Deep sleep	Percentage of deep sleep	at follow up after completion of treatment period (an average of three weeks)
Light sleep	Percentage of light sleep	at follow up after completion of treatment period (an average of three weeks)
Sleep latency	Latency of start of sleep in minutes	at follow up after completion of treatment period (an average of three weeks)
REM latency	Latency of start of REM sleep in minutes	at follow up after completion of treatment period (an average of three weeks)
Total sleep time	Total sleep time in minutes	at follow up after completion of treatment period (an average of three weeks)

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Study Chair: Olivier Vanderveken, MD, PhD, Head of ENT department, UZA

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Stent; Obstructive Sleep Apnea; Snoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: B300201942080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No