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

Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea Syndromes; Syncope, Vasovagal
• Intervention / Treatment: Other: Sleep apnea treatment

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Vincent Puel, MD; Phone Number: +33 557810587; Email: vpuel001@gmail.com
• Study Contact Backup: Name: Isabelle Godard, MD; Email: illa.godard05@gmail.com

Study Locations

• France
  • Angers, France
    • Recruiting
    • University Hospitals of Angers
    • Principal Investigator: Frédéric Gagnadou, MD
  • Bordeaux, France
    • Recruiting
    • Clinique Bel Air
    • Principal Investigator: Vincent Puel, MD
    • Sub-Investigator: Isabelle Godard, MD
  • Bordeaux, France
    • Recruiting
    • University Hospitals of Bordeaux
    • Principal Investigator: Georgios Papaioannou, MD
    • Sub-Investigator: Philippe Gosse, MD
  • Grenoble, France
    • Recruiting
    • University Hospitals of Grenoble
    • Principal Investigator: Jean-Louis Pépin, MD
  • Marseille, France
    • Recruiting
    • Clinique Bouchard
    • Principal Investigator: Fabrice Thoin, MD
  • Marseille, France
    • Recruiting
    • Public Assistance - Hospitals of Marseille
    • Principal Investigator: Jean-Claude Deharo, MD
  • Saint-Étienne, France
    • Recruiting
    • University Hospitals of Saint Etienne
    • Principal Investigator: Frédéric Roche, MD
• Monaco
  • Monaco, Monaco
    • Recruiting
    • Princess Grace Hospital
    • Principal Investigator: Naïma Zarqane, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence/absence of retrognathia	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
The presence/absence of archival palate	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
Mallampati score		Baseline (Day 0)
The presence/absence of anterior open bite	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
The presence/absence of cervico-mental angle blunting	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
Body mass index (kg/m2)		Baseline (Day 0)
Abdominal circumference (cm)		Baseline (Day 0)
Systolic blood pressure (mmHg) while lying down		Baseline (Day 0)
Systolic blood pressure (mmHg) while lying down after having remained in a standing position for 3 minutes		Baseline (Day 0)
Diastolic blood pressure (mmHg) while lying down		Baseline (Day 0)
Diastolic blood pressure (mmHg) after having remained in a standing position for 3 minutes		Baseline (Day 0)
Pulse (beats per minute) while lying down		Baseline (Day 0)
Pulse (beats per minute) after having remained in a standing position for 3 minutes		Baseline (Day 0)
Presence/absence of a positive table tilt test	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
Haemoglobin (g/dl)		Baseline (Day 0)
Haematocrit (%)		Baseline (Day 0)
Blood thyroid stimulating hormone (microU/l)		Baseline (Day 0)
Blood sodium levels (mmol/l)		Baseline (Day 0)
Blood potassium levels (mmol/l)		Baseline (Day 0)
Morning cortisol (mmol/l at 8 am)		Baseline (Day 0)

Collaborators and Investigators

• Sponsor: PEAS (Pole d'Exploration des Apnees du Sommeil)
• Investigators: Study Director: Vincent Puel, MD, Pôle d'exploration des apnées su sommeil (PEAS), Nouvelle Clinique Bel-Air - Bordeaux

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Anticipated): February 22, 2022
• Study Completion (Anticipated): February 22, 2022

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Signs and Symptoms, Respiratory; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Sleep Apnea Syndromes; Syndrome; Apnea; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: 2017-A03169-44 (Registry Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No