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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03169-44 | Registry Identifier | RCB number |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep apnea treatment | Other | Sleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD). |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The presence/absence of retrognathia | This is a binary variable indicating qualitative presence or absence of a particular condition. | Baseline (Day 0) |
| The presence/absence of archival palate | This is a binary variable indicating qualitative presence or absence of a particular condition. |
Inclusion Criteria:
Exclusion Criteria:
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The targeted study population consists of consecutive patients with both vasovagal syncope and sleep apnea syndrome with an indication for treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Puel, MD | Contact | +33 557810587 | vpuel001@gmail.com | |
| Isabelle Godard, MD | Contact | illa.godard05@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Puel, MD | Pôle d'exploration des apnées su sommeil (PEAS), Nouvelle Clinique Bel-Air - Bordeaux | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Angers | Recruiting | Angers | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32998925 | Derived | Puel V, Godard I, Papaioannou G, Gosse P, Pepin JL, Thoin F, Deharo JC, Roche F, Zarqane N, Gagnadoux F, Suehs CM, Molinari N. Management of sleep apnoea syndrome (SAS) in patients with vasovagal syncope (VVS): a protocol for the VVS-SAS cohort study. BMJ Open. 2020 Sep 30;10(9):e038791. doi: 10.1136/bmjopen-2020-038791. |
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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) |
| Baseline (Day 0) |
| Mallampati score | Baseline (Day 0) |
| The presence/absence of anterior open bite | This is a binary variable indicating qualitative presence or absence of a particular condition. | Baseline (Day 0) |
| The presence/absence of cervico-mental angle blunting | This is a binary variable indicating qualitative presence or absence of a particular condition. | Baseline (Day 0) |
| Body mass index (kg/m2) | Baseline (Day 0) |
| Abdominal circumference (cm) | Baseline (Day 0) |
| Systolic blood pressure (mmHg) while lying down | Baseline (Day 0) |
| Systolic blood pressure (mmHg) while lying down after having remained in a standing position for 3 minutes | Baseline (Day 0) |
| Diastolic blood pressure (mmHg) while lying down | Baseline (Day 0) |
| Diastolic blood pressure (mmHg) after having remained in a standing position for 3 minutes | Baseline (Day 0) |
| Pulse (beats per minute) while lying down | Baseline (Day 0) |
| Pulse (beats per minute) after having remained in a standing position for 3 minutes | Baseline (Day 0) |
| Presence/absence of a positive table tilt test | This is a binary variable indicating qualitative presence or absence of a particular condition. | Baseline (Day 0) |
| Haemoglobin (g/dl) | Baseline (Day 0) |
| Haematocrit (%) | Baseline (Day 0) |
| Blood thyroid stimulating hormone (microU/l) | Baseline (Day 0) |
| Blood sodium levels (mmol/l) | Baseline (Day 0) |
| Blood potassium levels (mmol/l) | Baseline (Day 0) |
| Morning cortisol (mmol/l at 8 am) | Baseline (Day 0) |
| Clinique Bel Air | Recruiting | Bordeaux | France |
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| University Hospitals of Bordeaux | Recruiting | Bordeaux | France |
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| University Hospitals of Grenoble | Recruiting | Grenoble | France |
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| Clinique Bouchard | Recruiting | Marseille | France |
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| Public Assistance - Hospitals of Marseille | Recruiting | Marseille | France |
|
| University Hospitals of Saint Etienne | Recruiting | Saint-Etienne | France |
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| Princess Grace Hospital | Recruiting | Monaco | Monaco |
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| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |