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

P

PEAS (Pole d'Exploration des Apnees du Sommeil)

Status

Unknown

Conditions

Syncope, Vasovagal
Sleep Apnea Syndromes

Treatments

Other: Sleep apnea treatment

Study type

Observational

Funder types

Other

Identifiers

NCT04294524
2017-A03169-44 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

8

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Central trial contact

Isabelle Godard, MD; Vincent Puel, MD

Data sourced from clinicaltrials.gov

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