Effect of High Intensity Focused Ultrasound on Sleep Quality Measures in Obese Doubled Chin Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- submental fat scale
研究概览
简要总结
This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.
详细描述
PURPOSE:
This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.
BACKGROUND:
High-intensity focused ultrasound (HIFU) therapy is becoming more familiar in medical field because it is non-invasive technique with fewer side effects and provides promising therapeutic results. Several HIFU therapy applications have approved by many approval authorities of deferent countries since last decade.
HIFU cauterizes tissue from outside the body by focusing ultrasonic waves from a transducer with many ultrasonic sources on a single point, known as the target tumor .This modality is groundbreaking because it only causes coagulative necrosis via thermal and non-thermal energy (mainly cavitation) to the focal area, with hardly any impact on the intervening tissue outside the focal area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
DOUBLE BLIND
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients that will be included in this study will meet the following criteria:
- •Female subjects with age ranged from 35 to 50 years old.
- •BMI will be 30-39.
- •BMI was classified into six groups:
- •underweight (<18.5 kg/m2) normal (18.5-24.9 kg/m2) pre-obesity (25-29.9 kg/m2) obesity class I (30-34.9 kg/m2) obesity class II (35-39.9 kg/m2) obesity class III (>40 kg/m2)
- •Clinically and medically stable.
- •Able to understand the requirements of the study. 5.Thyroxin normal level( thyroid-stimulating hormone) (0.35 and 5.0milli-International unit( mIU/L)
排除标准
- •The potential participants will be excluded if they meet one of the following criteria:
- •Neurological conditions (e.g., stroke history, Parkinson's disease).
- •Presence of an acute illness.
- •Renal and Hepatic diseases.
- •Patient undergoes chemotherapy.
- •Recent surgery.
- •Any contraindications for using HIFU such as:pregnancy ,metal prosthesis or implants,epilepsy,diabetes, autoimmune conditions,heart diseases including pacemaker,thrombosis .
- •8-BMI less than 30 and more than 39.
- •9-Age less than 35 and more than
- •10-Male subjects.
结局指标
主要结局
submental fat scale
时间窗: 3 months
It ranges from 0 (no localised sub-mental fat) to 4 (extreme submental convexity). The ideal patient for would be someone who is a '2' or '3' on sub-mental scale, so someone with moderate to severe sub-mental fullness
Spirometric assessment for obesity
时间窗: 3 months
patients underwent spirometry tests with measurement of forced expiratory volume in first second (FEV1), forced vital capacity (FVC)and(MVV)
Impact of Weight on Quality of Life Assessment Tools:
时间窗: 3 months
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated, 31-item, self-report measure of obesity-specific quality of life in adults, available in multiple languages. scale structure of the IWQOL-Lite has been verified with confirmatory factor analysis, and IWQOL-Lite scores are sensitive to changes in weight. There is strong evidence for validity and reliability. ▪ In addition to a total score, there are scores on five domains: * Physical function (11 items) * Self-esteem (7 items) * Sexual life (4 items) * Public distress (5 items) * Work (4 items) Scores range from 0 to 100, with 100 representing the best quality of life. Raw scores are no longer used for reporting
次要结局
- Assessment of hormonal changes(3 months)
- Assessment of snoring(3 months)
- Assessment of sleep apnea:(3 months)
研究者
Nahla Tharwat Mousa Ahmed
principal investigator
Cairo University