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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Insertion of the Nastent® to nostril during sleep hours
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.
Antwerp University Hospital
Edegem, Antwerp, Belgium
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)
Time frame: 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)
Time frame: at follow up after completion of treatment period (an average of three weeks)
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.)
Time frame: 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).
Time frame: Baseline
ODI (oxygen desaturation index)
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The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Body position
Percentage of supine, prone, left, right, upright position
Time frame: baseline
Snoring
Snoring loudness in decibels
Time frame: baseline
Oxygen saturation (SaO2)
A measurement of the percentage of how much hemoglobin is saturated with oxygen
Time frame: 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
Time frame: baseline
Sleep/wake state
Percentage of sleep and wake state
Time frame: baseline
REM sleep
Percentage of REM sleep
Time frame: baseline
Deep sleep
Percentage of deep sleep
Time frame: baseline
Light sleep
Percentage of light sleep
Time frame: baseline
Sleep latency
Latency of start of sleep in minutes
Time frame: baseline
REM latency
Latency of start of REM sleep in minutes
Time frame: baseline
Total sleep time
Total sleep time in minutes
Time frame: 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.)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at follow up after completion of treatment period (an average of three weeks)
Body position
Percentage of supine, prone, left, right, upright position
Time frame: at follow up after completion of treatment period (an average of three weeks)
Snoring
Snoring loudness in decibels
Time frame: 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
Time frame: 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
Time frame: at follow up after completion of treatment period (an average of three weeks)
Sleep/wake state
Percentage of sleep and wake state
Time frame: at follow up after completion of treatment period (an average of three weeks)
REM sleep
Percentage of REM sleep
Time frame: at follow up after completion of treatment period (an average of three weeks)
Deep sleep
Percentage of deep sleep
Time frame: at follow up after completion of treatment period (an average of three weeks)
Light sleep
Percentage of light sleep
Time frame: at follow up after completion of treatment period (an average of three weeks)
Sleep latency
Latency of start of sleep in minutes
Time frame: at follow up after completion of treatment period (an average of three weeks)
REM latency
Latency of start of REM sleep in minutes
Time frame: at follow up after completion of treatment period (an average of three weeks)
Total sleep time
Total sleep time in minutes
Time frame: at follow up after completion of treatment period (an average of three weeks)