Impact of 3-week SPA Therapy on Sleep Apnea in Patients With Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency: A Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 9
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).
详细描述
Obstructive Sleep Apnea Syndrome (OSAS), characterized by repetitive episodes of partial or complete upper airway (UA) obstruction, is highly prevalent in the general population (2% in women, 4% in men). OSAS is associated with hypersomnolence and it increases the risk of cardiovascular morbidity and mortality. Its pathogenesis is largely multifactorial. In patients with chronic venous insufficiency, fluid retention contributes to this pathogenesis: during the day, fluid accumulates in the legs due to gravity ; during sleep in recumbent position, this accumulated fluid redistributes rostrally in the neck and causes upper airway narrowing and predisposes to OSAS.
The hypothesis is that a comprehensive treatment program for chronic venous insufficiency (SPA therapy) would reduce sleep apnea in patients with chronic venous insufficiency and concomitant sleep apnea Syndrome.
The objective is to assess the efficacy of a 3-week SPA therapy on attenuation of sleep apnea in this population of patients.
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
- 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 Venous Insufficiency with oedema (CEAP clinical classes C3 to C5) and concomitant Sleep Apnea Syndrome (AHI > 15 events/hour)
- •Patient in stable state (no change in medical treatment and no hospitalization for respiratory, cardiac or metabolic event in the 2 months preceding inclusion)
- •Patient available for a program of 3-week SPA Therapy
排除标准
- •Patient with no social insurance
- •Pregnant and nursing woman
- •Patient detained by judicial order
- •Patient with contra-indication to SPA therapy
- •Patient with chronic venous insufficiency < CEAP C3 or CEAP C6
- •Patient already treated by class IV compression stockings for severe veinolymphatic insufficiency
- •Patient already treated for sleep apnea
- •Patient who have already benefited of SPA therapy (any type) within 9 months before the enrollment
- •Patient with severe comorbidities
- •Patient who could not respect the constraints related to the study
研究组 & 干预措施
Immediate SPA treatment
3-week immediate SPA treatment (soon after randomization)
干预措施: 3-week immediate SPA treatment (Other)
Late SPA treatment
3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit)
干预措施: 3-week late SPA treatment (Other)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: 4.5 months
Variation in AHI according to the allocation group
次要结局
- Nocturnal hypoxemia(4.5 months)
- Specific Quality of life(4.5 months)
- Global Quality of life(4.5 months)
- Clinically significant improvement of OSAS(4.5 months)
- Quality of Sleep(4.5 months)
- severity of sleep apnea(4.5 months)
- Sleep duration(4.5 months)
- Daytime sleepiness(4.5 months)
- Variation of interstitial fluid(4.5 months)
- Venous insufficiency variation(1 year)
- long term effect of the SPA treatment on primary outcome(1 year)
- Long term efficacy(1 year)
- long term effect of the SPA treatment on specific quality of life(1 year)
- long term effect of the SPA treatment on specific treatment of OSAS(1 year)
- Venous insufficiency classification(1 year)
- Venous insufficiency examination(1 year)
- long term effect of the SPA treatment on global quality of life(1 year)
- long term effect of the SPA treatment on venous insufficiency(1 year)
- benefit for patients with first SPA treatment(4.5 months)