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

PEAS (Pole d'Exploration des Apnees du Sommeil)60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Syncope, Vasovagal Sleep Apnea Syndromes

Interventions

Sleep apnea treatmentOTHER

Sleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

University Hospitals of Angers

Angers, France

RECRUITING

Clinique Bel Air

Bordeaux, France

RECRUITING

University Hospitals of Bordeaux

Bordeaux, France

Outcomes

Primary Outcomes

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.

Time frame: Month -6 to Day 0 versus Months +6 to +12

Secondary Outcomes

Syncope/malaise dates

Dates of syncopes/malaises throughout the study.

Time frame: Day 0 to Month 12

Patient-reported syncope/malaise frequency

never, rare, every three months, every month, every week, several times per week

Time frame: Baseline (Day 0)

Patient-reported syncope/malaise frequency

never, rare, every three months, every month, every week, several times per week

Time frame: Yearly visit (month 12)

Patient-reported position of syncopes/malaises

standing, sitting, lying down

Time frame: Baseline (Day 0)

Patient-reported position of syncopes/malaises

standing, sitting, lying down

Time frame: Yearly visit (month 12)

Patient-reported sycope/malaise trigger

heat, crowding, pain, stress, effort, lack of sleep, none

Time frame: Baseline (Day 0)

Patient-reported sycope/malaise trigger

Central Contacts

Vincent Puel, MD

CONTACT

+33 557810587 vpuel001@gmail.com

Isabelle Godard, MD

CONTACT

illa.godard05@gmail.com

Data from ClinicalTrials.gov

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University Hospitals of Grenoble

Grenoble, France

RECRUITING

Clinique Bouchard

Marseille, France

RECRUITING

Public Assistance - Hospitals of Marseille

Marseille, France

RECRUITING

University Hospitals of Saint Etienne

Saint-Etienne, France

RECRUITING

Princess Grace Hospital

Monaco, Monaco

RECRUITING

heat, crowding, pain, stress, effort, lack of sleep, none

Time frame: Yearly visit (month 12)

Patient-reported sycope/malaise timing

diurnal, nocturnal, postprandial, peri/post-miction/defecation

Time frame: Baseline (Day 0)

Patient-reported sycope/malaise timing

diurnal, nocturnal, postprandial, peri/post-miction/defecation

Time frame: Yearly visit (month 12)

Patient-reported frequency of signs preceding a loss of consciousness

always, sometimes, never

Time frame: Baseline (Day 0)

Patient-reported frequency of signs preceding a loss of consciousness

always, sometimes, never

Time frame: Yearly visit (month 12)

VAS for snoring