Ultrasound Against Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- polysomnography
研究概览
简要总结
To investigate the accuracy of neck ultrasound in identifying and discriminating the severity of obstructive sleep apnea (OSA).
Primary objective: To test the hypothesis that ultrasound can be used as a reliable tool for identifying the anatomic characteristics and dynamic changes of pharyngeal airspace in patients with OSA.
Secondary objective: Investigate if ultrasound can be used to discriminate OSA severity.
The investigators will compare these results to the results from polysomnography study.
详细描述
Investigators are conducting a prospective randomized control trial. Two-thirds of the participants will be randomly selected as the model-development group while the remaining one-third will serve as the validation group. The allocation will be based on a computer-generated random assignment. Ultrasonography and polysomnography operators will be blinded to other results.
Anthropometric Measurements:
Demographic data, including age, gender, weight (kilograms), body height (centimeters) and neck circumference (NC), will be recorded. Weight and height will be recorded with the patients wearing light clothes, but no shoes. Body mass index (BMI) will be then calculated as weight (kg) divided by height squared (mt2). NC will be measured (in cm) with a flexible tape at the level of the cricothyroid membrane after a gentle expiration by the subject while standing upright. History of hypertension, diabetes, hyperlipidemia or any other cardiovascular diseases will be recorded according to medical records or statements by the patients. All participants will be asked to complete the Epworth Sleepiness Scale (ESS), a subjective self-reported measure of excessive daytime sleepiness, within the same session before the ultrasound examination.
Polysomnography :
Full-night polysomnography (PSG) will be performed in the sleep laboratory according to protocol of sleep medicine department after US assessment. Apnea will be defined as the absence of airflow ≥10 sec and hypopnea will be defined as >50% decrease in airflow ≥10 sec associated with reduced arterial oxygen saturation by 4%, or an arousal. These two parameters are collectively defined as apnea-hypopnea index (AHI). An arousal will be recorded if there is a 3 second or longer abrupt shift in electroencephalogram frequency to alpha or theta or above 16 Hertz, following at least 10 seconds of sleep, and, if arising in rapid eye movement sleep, there should be a rise in electromyographic tone. An independent technician blinded to the US results will analyze the sleep studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- •All patients aged ≥18 years-old and who are arranged to receive polysomnography for suspected OSA, as per STOP BANG questionnaire, will be eligible for the study
排除标准
- •Refusal to participate
- •Inability to perform the maneuvers
- •Presence of congestive heart failure
- •Presence of chronic pulmonary disease demonstrated on pulmonary function testing
- •Active neurologic event
- •Active infection or surgery four weeks prior to screening
- •Active inflammation in head and neck region
- •Burns, trauma, radiotherapy involving head and neck region
- •Other diagnosis of sleep disorders
- •Ascites, benign or malignant abdominal mass and
- •Pregnancy
- •Craniofacial abnormalities
- •Presence of severe nasal obstruction
- •Oral cavity, Oropharyngeal or laryngeal masses
- •Cervical rigidity with limited neck flexion and head extension
- •No previous diagnosis of OSA or treatment instituted for OSA
- •Any patients whose PSG reports had a total sleep time of less than two hours or had no rapid eye movement sleep will be excluded from the study.
结局指标
主要结局
polysomnography
时间窗: 1 year
Apnea will be defined as the absence of airflow ≥10 sec and hypopnea will be defined as \>50% decrease in airflow ≥10 sec associated with reduced arterial oxygen saturation by 4%, or an arousal. These two parameters are collectively defined as apnea-hypopnea index (AHI). Episodes of AHI per hour will be used to diagnose and grade the severity of OSA: Non-OSA : \< 5/hr, mild OSA : 5- 14/hr, moderate OSA:15-29/hr and severe OSA : ≥30/hr.
Ultrasonographic exam of neck to measure of static and dynamic predictors of obstructive sleep apnea
时间窗: 1 Year
Investigators will measure Lateral parapharyngeal wall thickness (cms), upper airway length(cms), tongue base thickness(cms), subcutaneous fat thickness(cms), Retropalatal diameter(cms), Retroglossal diameter(cms) during normal tidal breathing as static indicators. Investigators will also measure tongue base thickness(cms), subcutaneous fat thickness(cms), Retropalatal diameter(cms), Retroglossal diameter (cms) during forced inspiratory maneuver and muller's maneuver as dynamic indicators. All measurements will be taken 3 times and mean will be reported. Investigators will calculate the percentage change in the above mentioned predictors during muller's maneuver Investigator will assess the predictive value of these variables in patients with obstructive sleep apnea, as diagnosed by Polysomnography.
Anthropometric measurement
时间窗: 1 year
Demographic data, including age, gender, weight (kilograms), body height (centimeters) and neck circumference (NC), will be recorded by a trained assistant in the sleep clinic. Weight and height will be recorded with the patients wearing light clothes, but no shoes. Body mass index (BMI) will be then calculated as weight (kg) divided by height squared (m2). NC will be measured (in cm) with a flexible tape at the level of the cricothyroid membrane after a gentle expiration by the subject while standing upright. History of hypertension, diabetes, hyperlipidemia or any other cardiovascular diseases will be recorded according to medical records or statements by the patients. All participants will be asked to complete the Epworth Sleepiness Scale (ESS), a subjective self-reported measure of excessive daytime sleepiness, within the same session before the ultrasound examination.
次要结局
未报告次要终点
研究者
Gaurav Chauhan
Resident physician
Henry Ford Health System