Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wake after sleep onset
研究概览
简要总结
The aim of the study is to evaluate the effect of nasal desobstruction surgery (septoplasty, septorhinoplasty or total ethmoidectomy) on sleep quality, assessed by the variation of the Wake after sleep onset (WASO), in patients presenting with sleep disorders and severe nasal obstruction.
详细描述
Obstructive sleep apnea syndrome (OSA) is a sleep breathing disorder characterised by episodes of complete or partial obstruction of the upper airway. OSA is a common disease which impacts quality of life, mood, cardiovascular morbidity, and mortality. It is often under-diagnosed and is estimated to affect at least 2-5% of the female population and 3-7% of the male population.
Currently, nasal obstruction is not recognised as an independent risk factor for obstructive sleep apnea syndrome. The current definition of OSA is based on an Apnea/Hypopnea index (AHI) greater than five. However, most studies do not find a decrease in this index after nasal desobstruction surgery despite a significant improvement in sleep quality scales. The AHI index appears to be a limited paraclinical criteria to assess the impact of nasal obstruction on sleep quality.
Other objective paraclinical criteria have been used in other nosological sleep settings to objectively assess sleep quality. These include the WASO (wake after sleep onset) criteria. To investigators knowledge, no study has assessed this parameter before and after a nasal desobstruction surgery.
The aim of the study is to evaluate the effect of nasal desobstruction surgery (septoplasty, septorhinoplasty or total ethmoidectomy) on sleep quality, assessed by the variation of the objective paraclinical criteria WASO, in patients presenting with sleep disorders and severe nasal obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patient with chronic severe nasal obstruction of inflammatory (PNS) and/or morphological (symptomatic septal deviation) requiring surgical management
- •NOSE > 9/20
- •BMI < 30 kg/m2
- •Over 18 years of age
- •Pittsburgh Sleep Quality Index (PSQI) greater than or equal to 5
排除标准
- •Patients with other sleep or wakefulness disorders: central sleep apnea syndromes, central hypersomnias including narcolepsy, parasomnia, restless legs syndrome and periodic leg movements.
- •Craniofacial developmental abnormalities that may be responsible for OSA (retrognathia, endognathia, micro-mandibula, ogival palate, other occlusive disorder)
- •Other identifiable obstructive site of the upper airways: tonsillar hypertrophy grade 3 and 4, macroglossia, unoperated vegetation hypertrophy, Mallampati score III or IV.
- •Suspicion of anxiety or depressive disorder on the Hospital Anxiety and Depression scale (HAD) screening scale with H>10 and/or A>
- •Use of psychotropic drugs or other respiratory depressant substances (morphine, chronic alcohol use, etc.)
- •Night worker
- •Other chronic rhinitis and rhinosinusitis
- •Uncontrolled allergies
- •Uncontrolled chronic respiratory disease
- •Pregnancy
- •Breastfeeding
- •Subjects referred to in articles L.1121-5 to L.1121-8 and L.1122-1-2 of the public health code (e.g.: protected adults, people in emergency situations, people unable to give their personal consent etc...)
- •Impossibility to understand the instructions and to answer in French
- •impossibility to participate in the entire study
- •no coverage by Social security
结局指标
主要结局
Wake after sleep onset
时间窗: 6 months after inclusion (M0)
Wake after sleep onset in minutes
次要结局
- Time in bed(Change from baseline (M0) and 4 month after surgery (M6))
- Sleep efficiency(Change from baseline (M0) and 4 month after surgery (M6))
- Pichot Qualitative Fatigue Scale score(Change from baseline (M0) and 4 month after surgery (M6))
- Sleep latency(Change from baseline (M0) and 4 month after surgery (M6))
- Pittsburgh Sleep Quality Index(Change from baseline (M0) and 4 month after surgery (M6))
- Total Sleep time(Change from baseline (M0) and 4 month after surgery (M6))
- Epworth Sleepiness Scale (ESS) score(Change from baseline (M0) and 4 month after surgery (M6))
- Nasal obstruction scale(Change from baseline (M0) and 4 month after surgery (M6))
- Insomnia Severity Index(Change from baseline (M0) and 4 month after surgery (M6))