NCT04618991已完成不适用
Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Score of the QSQ
研究概览
简要总结
The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.
详细描述
This assessment will be done using the following elements:
- The score of the Quebec sleep questionnaire (QSQ), developed in 2004 by Lacasse Y. et al. This questionnaire is specific to sleep apnea and may be self-administered. The main interest of this questionnaire is to measure the change in quality of life over time.
- The Epworth Scale Score, developed in 1991 by Murray W. John. This is a self-administered questionnaire developed to measure daytime sleepiness.
- Gender, age group, BMI
- The radiological assessment
- The results of polysomnography
Patients will be followed for a period of 1 year and one month after surgery. The protocol visits correspond to the rhythm of post-surgery follow-up consultations in current practice.
These patients are followed by Dr. Pételle at Saint-Antoine Hospital. During these visits, they will complete the Quebec sleep questionnaire and the Epworth scale, at baseline, at 3 months and then at 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult patients
- •With obstructive sleep apnea confirmed by polysomnography
- •Surgical indication for surgically maxillary expansion
排除标准
- •- Patients refusing to participate in the survey having formulated their opposition
- •Diabetes,
- •Obesity (BMI> 30)
- •Failure to provide informed written consent
- •Refusal or inability to return to all follow-up visits and sleep studies
- •Patient pregnant or planning to become pregnant in the next 12 months or breastfeeding
- •Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue or throat (Note that some previous surgeries, such as uvulopalatopharyngoplasty (UPPP), tonsillectomy or adenoidectomy, to remove obstructions related to obstructive sleep apnea are allowed)
- •Obvious obstructions of the fixed upper airways (tumors, polyps or nasal obstruction)
- •Patients who have undergone previous surgery on the mandible and / or maxilla, other than dental treatment.
- •Patients included in another clinical study (excluding registers).
- •Patients taking medicines such as opiates which may affect sleep, alertness or breathing
结局指标
主要结局
Score of the QSQ
时间窗: at 3 months
Score of the QSQ filled directly by the patient before surgery, compared to that then 3 months after surgery.
次要结局
- Epworth scale(at 1 year)
- correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data(at 1 year)
- Score of the Quebec Sleep Questionnaire (QSQ)(at 1 year)
- Polysomnography(at 3 months)
研究者
研究点 (2)
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