Sleep Apnea Syndromes, Syncope, Vasovagal
Conditions
Brief summary
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
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.
Interventions
Sleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD).
Sponsors
PEAS (Pole d'Exploration des Apnees du Sommeil)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-month syncope rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-item Impact of Syncope on Quality of Life (ISQL) questionnaire | Baseline (Day 0) | The ISQL has a possible range from 0 to 55. Higher scores indicate stronger impact of syncope on quality of life. |
| VAS for snoring | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| Syncope/malaise dates | Day 0 to Month 12 | Dates of syncopes/malaises throughout the study. |
| Patient-reported syncope/malaise frequency | Baseline (Day 0) | never, rare, every three months, every month, every week, several times per week |
| Patient-reported position of syncopes/malaises | Baseline (Day 0) | standing, sitting, lying down |
| Patient-reported sycope/malaise trigger | Baseline (Day 0) | heat, crowding, pain, stress, effort, lack of sleep, none |
| Patient-reported sycope/malaise timing | Baseline (Day 0) | diurnal, nocturnal, postprandial, peri/post-miction/defecation |
| Patient-reported frequency of signs preceding a loss of consciousness | Baseline (Day 0) | always, sometimes, never |
| VAS for nocturnal agitation | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for restless legs | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for nycturia | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for morning headaches | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for absence of libido | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for nocturnal sweating | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for gastro-oesophagien reflux | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for palpitations | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| VAS for lack of concentration while driving | Baseline (Day 0) | Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms). |
| the Epworth Sleepiness Scale | Baseline (Day 0) | This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness. |
| Pichot's fatigue scale | Baseline (Day 0) | This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue. |
| Pichot's depression inventory | Baseline (Day 0) | This scale ranges from 0 to 13. Higher scores indicate more elements of depression. |
| Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36)) | Baseline (Day 0) | The SF36 ranges from 0 to 100. Higher scores indicate higher quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mallampati score | Baseline (Day 0) | — |
| The presence/absence of anterior open bite | Baseline (Day 0) | This is a binary variable indicating qualitative presence or absence of a particular condition. |
| The presence/absence of cervico-mental angle blunting | Baseline (Day 0) | This is a binary variable indicating qualitative presence or absence of a particular condition. |
| 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 | Baseline (Day 0) | This is a binary variable indicating qualitative presence or absence of a particular condition. |
| 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) | — |
| The presence/absence of retrognathia | Baseline (Day 0) | This is a binary variable indicating qualitative presence or absence of a particular condition. |
| The presence/absence of archival palate | Baseline (Day 0) | This is a binary variable indicating qualitative presence or absence of a particular condition. |
Countries
France, Monaco
Contacts
Primary ContactVincent Puel, MD
Backup ContactIsabelle Godard, MD
Outcome results
None listed