Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, Snoring, Stent
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.
Interventions
DEVICENastent® (a distally perforated soft silicon nasal tube)
Insertion of the Nastent® to nostril during sleep hours
DIAGNOSTIC_TESTPolygraphy 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.
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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.) |
| 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 |
| 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 |
Countries
Belgium
Outcome results
None listed