The Use of Nasal Airway Stent (Nastent®) in Patients With Sleep-disordered Breathing (SDB) Including Snoring and/or Obstructive Sleep Apnea (OSA).
试验速览
- 阶段
- 不适用
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- AHI (apnea-hypopnea index)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI ≤ 20 per hour of sleep
- •Complaints of socially disturbing snoring by the partner of the patient
- •Capable of giving informed consent
排除标准
- •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
结局指标
主要结局
AHI (apnea-hypopnea index)
时间窗: 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)
次要结局
- Epworth sleepiness scale score (ESS)(at follow up after completion of treatment period (an average of three weeks))
- VAS (visual analogue scale) for snoring(at follow up after completion of treatment period (an average of three weeks))
- ODI (oxygen desaturation index)(at follow up after completion of treatment period (an average of three weeks))
- PAT (peripheral arterial tone) signal(at follow up after completion of treatment period (an average of three weeks))
- Heart rate(at follow up after completion of treatment period (an average of three weeks))
- Body position(at follow up after completion of treatment period (an average of three weeks))
- Snoring(at follow up after completion of treatment period (an average of three weeks))
- Oxygen saturation (SaO2)(at follow up after completion of treatment period (an average of three weeks))
- RDI (Respiratory disturbance index)(at follow up after completion of treatment period (an average of three weeks))
- Sleep/wake state(at follow up after completion of treatment period (an average of three weeks))
- REM sleep(at follow up after completion of treatment period (an average of three weeks))
- Deep sleep(at follow up after completion of treatment period (an average of three weeks))
- Light sleep(at follow up after completion of treatment period (an average of three weeks))
- Sleep latency(at follow up after completion of treatment period (an average of three weeks))
- REM latency(at follow up after completion of treatment period (an average of three weeks))
- Total sleep time(at follow up after completion of treatment period (an average of three weeks))
研究者
ethisch.comite@uza.be
Prof. Dr. Olivier Vanderveken
University Hospital, Antwerp