Nasal Airway Stent (Nastent®) Study in OSA

Obstructive Sleep Apnea Clinical Trial

— Nastent  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04305964
• Other study ID #: B300201942080
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	ODI (oxygen desaturation index)	The ODI represents the average number of desaturation episodes (=3%) per hour sleep.	baseline
Secondary	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
Secondary	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
Secondary	Body position	Percentage of supine, prone, left, right, upright position	baseline
Secondary	Snoring	Snoring loudness in decibels	baseline
Secondary	Oxygen saturation (SaO2)	A measurement of the percentage of how much hemoglobin is saturated with oxygen	baseline
Secondary	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
Secondary	Sleep/wake state	Percentage of sleep and wake state	baseline
Secondary	REM sleep	Percentage of REM sleep	baseline
Secondary	Deep sleep	Percentage of deep sleep	baseline
Secondary	Light sleep	Percentage of light sleep	baseline
Secondary	Sleep latency	Latency of start of sleep in minutes	baseline
Secondary	REM latency	Latency of start of REM sleep in minutes	baseline
Secondary	Total sleep time	Total sleep time in minutes	baseline
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Body position	Percentage of supine, prone, left, right, upright position	at follow up after completion of treatment period (an average of three weeks)
Secondary	Snoring	Snoring loudness in decibels	at follow up after completion of treatment period (an average of three weeks)
Secondary	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)
Secondary	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)
Secondary	Sleep/wake state	Percentage of sleep and wake state	at follow up after completion of treatment period (an average of three weeks)
Secondary	REM sleep	Percentage of REM sleep	at follow up after completion of treatment period (an average of three weeks)
Secondary	Deep sleep	Percentage of deep sleep	at follow up after completion of treatment period (an average of three weeks)
Secondary	Light sleep	Percentage of light sleep	at follow up after completion of treatment period (an average of three weeks)
Secondary	Sleep latency	Latency of start of sleep in minutes	at follow up after completion of treatment period (an average of three weeks)
Secondary	REM latency	Latency of start of REM sleep in minutes	at follow up after completion of treatment period (an average of three weeks)
Secondary	Total sleep time	Total sleep time in minutes	at follow up after completion of treatment period (an average of three weeks)