Clinical trial NCT04294524: Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS)
Official title: Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope, Vasovagal
Sleep Apnea Syndromes
Lead sponsor: PEAS (Pole d'Exploration des Apnees du Sommeil)
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The targeted study population consists of consecutive patients with both vasovagal syncope and sleep apnea syndrome with an indication for treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 6-month syncope rate
timeFrame: Month -6 to Day 0 versus Months +6 to +12
Secondary outcomes:
measure: Syncope/malaise dates
timeFrame: Day 0 to Month 12
measure: Patient-reported syncope/malaise frequency
timeFrame: Baseline (Day 0)
measure: Patient-reported syncope/malaise frequency
timeFrame: Yearly visit (month 12)
measure: Patient-reported position of syncopes/malaises
timeFrame: Baseline (Day 0)
measure: Patient-reported position of syncopes/malaises
timeFrame: Yearly visit (month 12)
measure: Patient-reported sycope/malaise trigger
timeFrame: Baseline (Day 0)
measure: Patient-reported sycope/malaise trigger
timeFrame: Yearly visit (month 12)
measure: Patient-reported sycope/malaise timing
timeFrame: Baseline (Day 0)
measure: Patient-reported sycope/malaise timing
timeFrame: Yearly visit (month 12)
measure: Patient-reported frequency of signs preceding a loss of consciousness
timeFrame: Baseline (Day 0)
measure: Patient-reported frequency of signs preceding a loss of consciousness
timeFrame: Yearly visit (month 12)
measure: VAS for snoring
timeFrame: Baseline (Day 0)
measure: VAS for snoring
timeFrame: Yearly visit (month 12)
measure: VAS for nocturnal agitation
timeFrame: Baseline (Day 0)
measure: VAS for nocturnal agitation
timeFrame: Yearly visit (month 12)
measure: VAS for restless legs
timeFrame: Baseline (Day 0)
measure: VAS for restless legs
timeFrame: Yearly visit (month 12)
measure: VAS for nycturia
timeFrame: Baseline (Day 0)
measure: VAS for nycturia
timeFrame: Yearly visit (month 12)
measure: VAS for morning headaches
timeFrame: Baseline (Day 0)
measure: VAS for morning headaches
timeFrame: Yearly visit (month 12)
measure: VAS for absence of libido
timeFrame: Baseline (Day 0)
measure: VAS for absence of libido
timeFrame: Yearly visit (month 12)
measure: VAS for nocturnal sweating
timeFrame: Baseline (Day 0)
measure: VAS for nocturnal sweating
timeFrame: Yearly visit (month 12)
measure: VAS for gastro-oesophagien reflux
timeFrame: Baseline (Day 0)
measure: VAS for gastro-oesophagien reflux
timeFrame: Yearly visit (month 12)
measure: VAS for palpitations
timeFrame: Baseline (Day 0)
measure: VAS for palpitations
timeFrame: Yearly visit (month 12)
measure: VAS for lack of concentration while driving
timeFrame: Baseline (Day 0)
measure: VAS for lack of concentration while driving
timeFrame: Yearly visit (month 12)
measure: 12-item Impact of Syncope on Quality of Life (ISQL) questionnaire
timeFrame: Baseline (Day 0)
measure: 12-item Impact of Syncope on Quality of Life (ISQL) questionnaire
timeFrame: Yearly visit (month 12)
measure: the Epworth Sleepiness Scale
timeFrame: Baseline (Day 0)
measure: the Epworth Sleepiness Scale
timeFrame: Yearly visit (month 12)
measure: Pichot's fatigue scale
timeFrame: Baseline (Day 0)
measure: Pichot's fatigue scale
timeFrame: Yearly visit (month 12)
measure: Pichot's depression inventory
timeFrame: Baseline (Day 0)
measure: Pichot's depression inventory
timeFrame: Yearly visit (month 12)
measure: Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
timeFrame: Baseline (Day 0)
measure: Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
timeFrame: Yearly visit (month 12)
Other outcomes:
measure: The presence/absence of retrognathia
timeFrame: Baseline (Day 0)
measure: The presence/absence of archival palate
timeFrame: Baseline (Day 0)
measure: Mallampati score
timeFrame: Baseline (Day 0)
measure: The presence/absence of anterior open bite
timeFrame: Baseline (Day 0)
measure: The presence/absence of cervico-mental angle blunting
timeFrame: Baseline (Day 0)
measure: Body mass index (kg/m2)
timeFrame: Baseline (Day 0)
measure: Abdominal circumference (cm)
timeFrame: Baseline (Day 0)
measure: Systolic blood pressure (mmHg) while lying down
timeFrame: Baseline (Day 0)
measure: Systolic blood pressure (mmHg) while lying down after having remained in a standing position for 3 minutes
timeFrame: Baseline (Day 0)
measure: Diastolic blood pressure (mmHg) while lying down
timeFrame: Baseline (Day 0)
measure: Diastolic blood pressure (mmHg) after having remained in a standing position for 3 minutes
timeFrame: Baseline (Day 0)
measure: Pulse (beats per minute) while lying down
timeFrame: Baseline (Day 0)
measure: Pulse (beats per minute) after having remained in a standing position for 3 minutes
timeFrame: Baseline (Day 0)
measure: Presence/absence of a positive table tilt test
timeFrame: Baseline (Day 0)
measure: Haemoglobin (g/dl)
timeFrame: Baseline (Day 0)
measure: Haematocrit (%)
timeFrame: Baseline (Day 0)
measure: Blood thyroid stimulating hormone (microU/l)
timeFrame: Baseline (Day 0)
measure: Blood sodium levels (mmol/l)
timeFrame: Baseline (Day 0)
measure: Blood potassium levels (mmol/l)
timeFrame: Baseline (Day 0)
measure: Morning cortisol (mmol/l at 8 am)
timeFrame: Baseline (Day 0)
Locations:
city: Angers
country: France
facility: University Hospitals of Angers
city: Bordeaux
country: France
facility: Clinique Bel Air
city: Bordeaux
country: France
facility: University Hospitals of Bordeaux
city: Grenoble
country: France
facility: University Hospitals of Grenoble
city: Marseille
country: France
facility: Clinique Bouchard
city: Marseille
country: France
facility: Public Assistance - Hospitals of Marseille
city: Saint-Étienne
country: France
facility: University Hospitals of Saint Etienne
city: Monaco
country: Monaco
facility: Princess Grace Hospital
Study officials:
affiliation: Pôle d'exploration des apnées su sommeil (PEAS), Nouvelle Clinique Bel-Air - Bordeaux
name: Vincent Puel, MD
role: STUDY_DIRECTOR
References:
citation: 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.