Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study

Conditions
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Syncope, Vasovagal, Sleep Apnea Syndromes

Intervention / Treatment
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* Other: Sleep apnea treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Sleep apnea treatment|Sleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-month syncope rate | 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. | Month -6 to Day 0 versus Months +6 to +12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syncope/malaise dates | Dates of syncopes/malaises throughout the study. | Day 0 to Month 12 | 
| Patient-reported syncope/malaise frequency | never, rare, every three months, every month, every week, several times per week | Baseline (Day 0) | 
| Patient-reported syncope/malaise frequency | never, rare, every three months, every month, every week, several times per week | Yearly visit (month 12) | 
| Patient-reported position of syncopes/malaises | standing, sitting, lying down | Baseline (Day 0) | 
| Patient-reported position of syncopes/malaises | standing, sitting, lying down | Yearly visit (month 12) | 
| Patient-reported sycope/malaise trigger | heat, crowding, pain, stress, effort, lack of sleep, none | Baseline (Day 0) | 
| Patient-reported sycope/malaise trigger | heat, crowding, pain, stress, effort, lack of sleep, none | Yearly visit (month 12) | 
| Patient-reported sycope/malaise timing | diurnal, nocturnal, postprandial, peri/post-miction/defecation | Baseline (Day 0) | 
| Patient-reported sycope/malaise timing | diurnal, nocturnal, postprandial, peri/post-miction/defecation | Yearly visit (month 12) | 
| Patient-reported frequency of signs preceding a loss of consciousness | always, sometimes, never | Baseline (Day 0) | 
| Patient-reported frequency of signs preceding a loss of consciousness | always, sometimes, never | Yearly visit (month 12) | 
| VAS for snoring | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for snoring | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for nocturnal agitation | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for nocturnal agitation | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for restless legs | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for restless legs | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for nycturia | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for nycturia | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for morning headaches | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for morning headaches | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for absence of libido | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for absence of libido | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for nocturnal sweating | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for nocturnal sweating | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for gastro-oesophagien reflux | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for gastro-oesophagien reflux | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for palpitations | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for palpitations | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| VAS for lack of concentration while driving | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Baseline (Day 0) | 
| VAS for lack of concentration while driving | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). | Yearly visit (month 12) | 
| 12-item Impact of Syncope on Quality of Life (ISQL) questionnaire | The ISQL has a possible range from 0 to 55. Higher scores indicate stronger impact of syncope on quality of life. | Baseline (Day 0) | 
| 12-item Impact of Syncope on Quality of Life (ISQL) questionnaire | The ISQL has a possible range from 0 to 55. Higher scores indicate stronger impact of syncope on quality of life. | Yearly visit (month 12) | 
| the Epworth Sleepiness Scale | This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness. | Baseline (Day 0) | 
| the Epworth Sleepiness Scale | This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness. | Yearly visit (month 12) | 
| Pichot's fatigue scale | This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue. | Baseline (Day 0) | 
| Pichot's fatigue scale | This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue. | Yearly visit (month 12) | 
| Pichot's depression inventory | This scale ranges from 0 to 13. Higher scores indicate more elements of depression. | Baseline (Day 0) | 
| Pichot's depression inventory | This scale ranges from 0 to 13. Higher scores indicate more elements of depression. | Yearly visit (month 12) | 
| Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) | The SF36 ranges from 0 to 100. Higher scores indicate higher quality of life. | Baseline (Day 0) | 
| Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) | The SF36 ranges from 0 to 100. Higher scores indicate higher quality of life. | Yearly visit (month 12) |