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

NCT04294524 | Unknown

• 1 other identifier: 2017-A03169-44
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 8

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.

Conditions

Syncope, Vasovagal; Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• 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.

  Month -6 to Day 0 versus Months +6 to +12

Secondary Outcomes (41)

• Syncope/malaise dates

  Day 0 to Month 12

• Patient-reported syncope/malaise frequency

  Baseline (Day 0)

• Patient-reported syncope/malaise frequency

  Yearly visit (month 12)

• Patient-reported position of syncopes/malaises

  Baseline (Day 0)

• Patient-reported position of syncopes/malaises

  Yearly visit (month 12)

Other Outcomes (20)

• The presence/absence of retrognathia

  Baseline (Day 0)

• The presence/absence of archival palate

  Baseline (Day 0)

• Mallampati score

  Baseline (Day 0)

Interventions

Sleep apnea treatment OTHER

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• PEAS (Pole d'Exploration des Apnees du Sommeil): lead

Study Sites (8)

University Hospitals of Angers

Angers, France

RECRUITING

Clinique Bel Air

Bordeaux, France

RECRUITING

University Hospitals of Bordeaux

Bordeaux, France

RECRUITING

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

Related Publications (1)

• 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.

  PMID: 32998925 DERIVED

MeSH Terms

Conditions

Syncope, Vasovagal; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Vincent Puel, MD

  Pôle d'exploration des apnées su sommeil (PEAS), Nouvelle Clinique Bel-Air - Bordeaux

  STUDY DIRECTOR

Central Study Contacts

Vincent Puel, MD

CONTACT

+33 557810587; vpuel001@gmail.com

Isabelle Godard, MD

CONTACT

illa.godard05@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 4, 2020
• Study Start: February 22, 2017
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

FR (7); MO (1)