Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Change in 6-month syncope rate
研究概览
简要总结
This is a multi-centre, registry-based study whose primary objective is to evaluate the effect of treatment for sleep apnoea syndrome (SAS) on the number of syncope/malaise episodes in a population suffering from both idiopathic, recurrent vasovagal syncope/malaises and SAS.
详细描述
Treatment for sleep apnoea syndrome includes continuous positive airway pressure (CPAP) or a mandibular advancement device (MAD). Additional routine follow-up includes 24 hour holter monitoring on a yearly basis, polysomnography on a yearly basis, multiple sleep latency tests, table tilt tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Obstructive sleep apnoea syndrome (>15 respiratory micro awakenings per hour of sleep) with an indication for treatment
- •Recurring vasovagal syncope episodes defined as follows: at least three vasovagal syncopes during the last two years - OR- symptoms of orthostatic intolerance occurring in the last 6 months (Symptoms are triggered by orthostatism and can include malaises without loss of consciousness, asthenia, dizziness, visual disturbances, tinnitus, palpitations, headache, limitations of physical activity)
排除标准
- •Pathology that may explain syncope symptoms
- •Cardiopathy
- •Known disautonomia
- •Hypotension of known origin
- •Adrenal insufficiency
- •Thyroid disorder
- •History of sudden death in a first degree family member
结局指标
主要结局
Change in 6-month syncope rate
时间窗: Month -6 to Day 0 versus Months +6 to +12
Day 0 refers to the initiation of sleep apnea treatment. The baseline syncope rate refers to syncope events occurring between month -6 and day 0 (S_before). The post-treatment syncope rate refers to syncope events occurring between months +6 and +12(S_after). The change is rates is S_before minus S_after.
次要结局
- Patient-reported position of syncopes/malaises(Yearly visit (month 12))
- Patient-reported frequency of signs preceding a loss of consciousness(Yearly visit (month 12))
- VAS for snoring(Yearly visit (month 12))
- VAS for nycturia(Yearly visit (month 12))
- 12-item Impact of Syncope on Quality of Life (ISQL) questionnaire(Yearly visit (month 12))
- VAS for nocturnal agitation(Yearly visit (month 12))
- VAS for nocturnal sweating(Yearly visit (month 12))
- Syncope/malaise dates(Day 0 to Month 12)
- Patient-reported sycope/malaise trigger(Yearly visit (month 12))
- VAS for absence of libido(Yearly visit (month 12))
- Patient-reported syncope/malaise frequency(Yearly visit (month 12))
- Patient-reported sycope/malaise timing(Yearly visit (month 12))
- VAS for restless legs(Yearly visit (month 12))
- VAS for palpitations(Yearly visit (month 12))
- VAS for morning headaches(Yearly visit (month 12))
- VAS for gastro-oesophagien reflux(Yearly visit (month 12))
- the Epworth Sleepiness Scale(Yearly visit (month 12))
- Pichot's fatigue scale(Yearly visit (month 12))
- VAS for lack of concentration while driving(Yearly visit (month 12))
- Pichot's depression inventory(Yearly visit (month 12))
- Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))(Yearly visit (month 12))
研究者
Vincent Puel
Study Director
PEAS (Pole d'Exploration des Apnees du Sommeil)