NCT01117974撤回不适用
Neck Liposuction With Tumescent Anesthesia for the Treatment of Obstructive Sleep Apnea - A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
Liposuction, one of the most common cosmetic procedures performed in the United States, is a surgical technique used to reduce localized areas of excess subcutaneous fat. The neck is a common area of treatment, where liposuction reduces fat volume and neck size. We hypothesize that suctioned removal of fat of the neck will reduce the severity of obstructive sleep apnea.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years of age
- •Subjects must have documented mild to moderate obstructive sleep apnea(OSA) syndrome within the last year from the Northwestern University Sleep Clinic
- •Subjects must qualify as "very sleepy" on the Epworth Sleepiness Scale
- •Females must have neck circumference of 16.0 cm or greater, and males must have neck circumference of 17.0 cm or greater
- •Subjects must be a good candidates for neck liposuction as determined by the study physician
- •Subjects must be in good health and is able to undergo the liposuction procedure
排除标准
- •Pregnant or lactating female
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects dependent on blood thinners
- •Subjects with bleeding diathesis
- •Subjects with a history of poor wound healing, skin fragility, poor skin elasticity, or hypertrophic or keloidal scarring
- •Subjects with a history of excessive surgeries on the neck in the area to be treated
- •Subjects who are allergic to lidocaine or who have previously had an adverse reaction to epinephrine
- •Subjects with non-apnea sleep disorders such as restless leg syndrome, insomnia, circadian rhythm disorders
- •Subjects with chronic obstructive pulmonary disease
- •Subjects with craniofacial abnormalities
- •Subjects with hypoventilation
- •Subjects with large tonsils/adenoids or an abnormal airway exam as determined by the study physician
- •Subjects with an anatomical nasal obstruction
- •Subjects who have a large tongue
- •Subjects with severe cardiopulmonary risks as determined by the study physician
- •Subjects who cannot complete an MRI
- •Subjects who intend to pursue other treatments for OSA during the duration of this study
- •Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area
- •Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment
- •Subjects with a Body Mass Index >35kg/m2
- •Subjects treated with continuous positive airway pressure (CPAP) within one month of study enrollment
结局指标
主要结局
Apnea-hypopnea index
时间窗: Baseline (0 weeks)
Change in the apnea-hypopnea index
时间窗: 12 weeks
次要结局
- Sleep-related quality of life(Baseline (Week 0))
- Change in sleep-related quality of life(12 weeks)
研究者
Dennis West
Associate Professor of Dermatology
Northwestern University
相似试验
已完成
不适用
Methemoglobinemia After Liposuction - Diagnostic by Pulse Oximetry and Blood Gas Analysis.MethemoglobinemiaNCT01766999University Hospital Schleswig-Holstein133
Unknown
4 期
EXPAREL Post-tonsillectomy Clinical TrialTonsillectomyNCT03420638Paul Hoff38
进行中（未招募）
不适用
WashIn /WashOut Procedure To Prevent Agitation During Recovery After Inhalational Anesthesia With SevofluraneAgitation, EmergencePostoperative DeliriumPostoperative Cognitive DysfunctionNCT04765488I.M. Sechenov First Moscow State Medical University200
Unknown
不适用
Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty SurgeryAbdominoplastyNCT03940885Mansoura University69
终止
不适用
Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese PatientGeneral SurgeryNCT02894073Centre Hospitalier Universitaire, Amiens2