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

• Conditions: Sleep Apnea Syndromes; Syncope, Vasovagal

• Registration Number: NCT04294524
• Lead Sponsor: PEAS (Pole d'Exploration des Apnees du Sommeil)

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.

Study Timeline

• Study Start: 2017-02-22
• Status Verified: 2020-03
• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 6-month syncope rate	Month -6 to Day 0 versus Months +6 to +12	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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported position of syncopes/malaises	Yearly visit (month 12)	standing, sitting, lying down
Patient-reported frequency of signs preceding a loss of consciousness	Yearly visit (month 12)	always, sometimes, never
VAS for snoring	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
VAS for nycturia	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
12-item Impact of Syncope on Quality of Life (ISQL) questionnaire	Yearly visit (month 12)	The ISQL has a possible range from 0 to 55. Higher scores indicate stronger impact of syncope on quality of life.
VAS for nocturnal agitation	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
VAS for nocturnal sweating	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Syncope/malaise dates	Day 0 to Month 12	Dates of syncopes/malaises throughout the study.
Patient-reported sycope/malaise trigger	Yearly visit (month 12)	heat, crowding, pain, stress, effort, lack of sleep, none
Patient-reported syncope/malaise frequency	Yearly visit (month 12)	never, rare, every three months, every month, every week, several times per week
Patient-reported sycope/malaise timing	Yearly visit (month 12)	diurnal, nocturnal, postprandial, peri/post-miction/defecation
VAS for restless legs	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
VAS for absence of libido	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
VAS for morning headaches	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
VAS for gastro-oesophagien reflux	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
VAS for palpitations	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
the Epworth Sleepiness Scale	Yearly visit (month 12)	This questionnaire describes sleepiness with a score that ranges from 0 to 24. Higher scores indicate more sleepiness.
Pichot's fatigue scale	Yearly visit (month 12)	This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue.
VAS for lack of concentration while driving	Yearly visit (month 12)	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Pichot's depression inventory	Yearly visit (month 12)	This scale ranges from 0 to 13. Higher scores indicate more elements of depression.
Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))	Yearly visit (month 12)	The SF36 ranges from 0 to 100. Higher scores indicate higher quality of life.

Trial Locations

Locations (8)

Public Assistance - Hospitals of Marseille; 🇫🇷 Marseille, France

University Hospitals of Bordeaux; 🇫🇷 Bordeaux, France

Princess Grace Hospital; 🇲🇨 Monaco, Monaco

Clinique Bel Air; 🇫🇷 Bordeaux, France

University Hospitals of Saint Etienne; 🇫🇷 Saint-Étienne, France

Clinique Bouchard; 🇫🇷 Marseille, France

University Hospitals of Angers; 🇫🇷 Angers, France

University Hospitals of Grenoble; 🇫🇷 Grenoble, France