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

Last updated: March 3, 2020
Sponsor: PEAS (Pole d'Exploration des Apnees du Sommeil)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Orthostatic Hypotension

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT04294524
2017-A03169-44
2017-A03169-44
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 vasovagalsyncopes during the last two years - OR- symptoms of orthostatic intolerance occurringin the last 6 months (Symptoms are triggered by orthostatism and can include malaiseswithout loss of consciousness, asthenia, dizziness, visual disturbances, tinnitus,palpitations, headache, limitations of physical activity)

Exclusion

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

Study Design

Total Participants: 60
Study Start date:
February 22, 2017
Estimated Completion Date:
February 22, 2022

Study 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.

Connect with a study center

  • University Hospitals of Angers

    Angers,
    France

    Active - Recruiting

  • Clinique Bel Air

    Bordeaux,
    France

    Active - Recruiting

  • University Hospitals of Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • University Hospitals of Grenoble

    Grenoble,
    France

    Active - Recruiting

  • Clinique Bouchard

    Marseille,
    France

    Active - Recruiting

  • Public Assistance - Hospitals of Marseille

    Marseille,
    France

    Active - Recruiting

  • University Hospitals of Saint Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • Princess Grace Hospital

    Monaco,
    Monaco

    Active - Recruiting

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