Nasal Airway Stent (Nastent®) Study in OSA

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04305964

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Nastent® (a distally perforated soft silicon nasal tube) Diagnostic Test: Polygraphy with WatchPAT™ 300	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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:

Outcome Measures

Primary Outcome Measures

AHI (apnea-hypopnea index) [At baseline]
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)
AHI (apnea-hypopnea index) [at follow up after completion of treatment period (an average of three weeks)]
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)

Secondary Outcome Measures

Epworth sleepiness scale score (ESS) [baseline]
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.)
VAS (visual analogue scale) for snoring [Baseline]
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).
ODI (oxygen desaturation index) [baseline]
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
PAT (peripheral arterial tone) signal [baseline]
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.
Heart rate [baseline]
The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.
Body position [baseline]
Percentage of supine, prone, left, right, upright position
Snoring [baseline]
Snoring loudness in decibels
Oxygen saturation (SaO2) [baseline]
A measurement of the percentage of how much hemoglobin is saturated with oxygen
RDI (Respiratory disturbance index) [baseline]
Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea
Sleep/wake state [baseline]
Percentage of sleep and wake state
REM sleep [baseline]
Percentage of REM sleep
Deep sleep [baseline]
Percentage of deep sleep
Light sleep [baseline]
Percentage of light sleep
Sleep latency [baseline]
Latency of start of sleep in minutes
REM latency [baseline]
Latency of start of REM sleep in minutes
Total sleep time [baseline]
Total sleep time in minutes
Epworth sleepiness scale score (ESS) [at follow up after completion of treatment period (an average of three weeks)]
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.)
VAS (visual analogue scale) for snoring [at follow up after completion of treatment period (an average of three weeks)]
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).
ODI (oxygen desaturation index) [at follow up after completion of treatment period (an average of three weeks)]
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
PAT (peripheral arterial tone) signal [at follow up after completion of treatment period (an average of three weeks)]
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.
Heart rate [at follow up after completion of treatment period (an average of three weeks)]
The number of times a person's heart beats per minute. Normal heart rate range for adults is 60 to 100 beats per minute.
Body position [at follow up after completion of treatment period (an average of three weeks)]
Percentage of supine, prone, left, right, upright position
Snoring [at follow up after completion of treatment period (an average of three weeks)]
Snoring loudness in decibels
Oxygen saturation (SaO2) [at follow up after completion of treatment period (an average of three weeks)]
A measurement of the percentage of how much hemoglobin is saturated with oxygen
RDI (Respiratory disturbance index) [at follow up after completion of treatment period (an average of three weeks)]
Number of apneas, hypopneas and respiratory-effort related arousals (RERAs) per hour of sleep which is an indicator of severity of sleep apnea
Sleep/wake state [at follow up after completion of treatment period (an average of three weeks)]
Percentage of sleep and wake state
REM sleep [at follow up after completion of treatment period (an average of three weeks)]
Percentage of REM sleep
Deep sleep [at follow up after completion of treatment period (an average of three weeks)]
Percentage of deep sleep
Light sleep [at follow up after completion of treatment period (an average of three weeks)]
Percentage of light sleep
Sleep latency [at follow up after completion of treatment period (an average of three weeks)]
Latency of start of sleep in minutes
REM latency [at follow up after completion of treatment period (an average of three weeks)]
Latency of start of REM sleep in minutes
Total sleep time [at follow up after completion of treatment period (an average of three weeks)]
Total sleep time in minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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