Obstructive Sleep Apnea Syndrome (OSAS) and Dizziness
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- The change in the score on Dizziness Handicap Inventory (DHI)
研究概览
简要总结
A total of 400 participants will be recruited: 200 patients with suspected OSAS will be recruited from the sleep clinic (OSAS group), 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group). In addition, 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls). Informed consents will be completed by all participants. ). In order to assess the effect of treatment of OSAS on dizziness -patients with the diagnosis of OSAS will complete validated questionnaires regarding sleep, dizziness and eustachian tube function 3 months following initiation of treatment with CPAP
详细描述
Group 1 - 200 patients with OSAS based on sleep study will be recruited from the sleep clinic (OSAS group) Group 2 - 100 patients diagnosed with dizziness will be recruited from the ENT clinic (Dizziness group).
Group 3 - 100 patients with no dizziness and no evidence for OSAS will be recruited from both the sleep clinic and the ENT clinic (controls).
Informed consents will be completed by all participants. All participants will undergo thorough physical examination with particular attention to the vestibular system, otoscopy, examination of the pharynx including with a flexible endoscope (that is part of the standard ENT examination). The examiner will photo-document the nasopharynx as needed.
Demographics and complete medical history will be recorded for each participant.
All participants will complete the following validated questionnaires:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-90 years
- •Group 1: subjects diagnosed with OSAS based sleep study
- •Group 2: subjects referred to the ENT clinic with major complaint of dizziness (defined as a non-spinning sensation, without illusion of movement)
- •Group 3: subjects referred for the ENT or the Sleep clinic with no dizziness and no evidence of OSAS
排除标准
- •Neurological and psychiatric disorders
- •Pregnant women
- •Subjects with judgment difficulties
- •Subjects that will be diagnosed with specific pathology that explains their dizziness.
- •Subjects previously diagnosed and treated surgically for OSAS .
- •Subjects with any previous intervention on the soft palate base tongue or pharynx (not including adenotonsillectomy).
- •Subjects with any congenital anomaly of the palate and pharynx
结局指标
主要结局
The change in the score on Dizziness Handicap Inventory (DHI)
时间窗: 3 months after beginning of use of CPAP
The change in the total score on the DHI before and after the use of CPAP in (minimum score:0, maximum score: 100. Higher values represent worsening of the dizziness) OSAS patients
次要结局
未报告次要终点