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

Sleep Apnea Syndromes Clinical Trial

— VVS-SAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04294524
• Other study ID #: 2017-A03169-44
• Secondary ID: 2017-A03169-44
• Status: Recruiting
• Start date: February 22, 2017
• Est. completion date: February 22, 2022

Study information

• Verified date: March 2020
• Source: PEAS (Pole d'Exploration des Apnees du Sommeil)
• Contact: Vincent Puel, MD
• Phone: +33 557810587
• Email: vpuel001[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Syncope
• Syncope, Vasovagal
• Syndrome

Intervention

Other:
• Sleep apnea treatment
Sleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD).

Locations

Country	Name	City	State
France	University Hospitals of Angers	Angers
France	Clinique Bel Air	Bordeaux
France	University Hospitals of Bordeaux	Bordeaux
France	University Hospitals of Grenoble	Grenoble
France	Clinique Bouchard	Marseille
France	Public Assistance - Hospitals of Marseille	Marseille
France	University Hospitals of Saint Etienne	Saint-Étienne
Monaco	Princess Grace Hospital	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
PEAS (Pole d'Exploration des Apnees du Sommeil)

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The presence/absence of retrognathia	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
Other	The presence/absence of archival palate	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
Other	Mallampati score		Baseline (Day 0)
Other	The presence/absence of anterior open bite	This is a binary variable indicating qualitative presence or absence of a particular condition.	Baseline (Day 0)
Other	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)
Other	Body mass index (kg/m2)		Baseline (Day 0)
Other	Abdominal circumference (cm)		Baseline (Day 0)
Other	Systolic blood pressure (mmHg) while lying down		Baseline (Day 0)
Other	Systolic blood pressure (mmHg) while lying down after having remained in a standing position for 3 minutes		Baseline (Day 0)
Other	Diastolic blood pressure (mmHg) while lying down		Baseline (Day 0)
Other	Diastolic blood pressure (mmHg) after having remained in a standing position for 3 minutes		Baseline (Day 0)
Other	Pulse (beats per minute) while lying down		Baseline (Day 0)
Other	Pulse (beats per minute) after having remained in a standing position for 3 minutes		Baseline (Day 0)
Other	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)
Other	Haemoglobin (g/dl)		Baseline (Day 0)
Other	Haematocrit (%)		Baseline (Day 0)
Other	Blood thyroid stimulating hormone (microU/l)		Baseline (Day 0)
Other	Blood sodium levels (mmol/l)		Baseline (Day 0)
Other	Blood potassium levels (mmol/l)		Baseline (Day 0)
Other	Morning cortisol (mmol/l at 8 am)		Baseline (Day 0)
Primary	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	Syncope/malaise dates	Dates of syncopes/malaises throughout the study.	Day 0 to Month 12
Secondary	Patient-reported syncope/malaise frequency	never, rare, every three months, every month, every week, several times per week	Baseline (Day 0)
Secondary	Patient-reported syncope/malaise frequency	never, rare, every three months, every month, every week, several times per week	Yearly visit (month 12)
Secondary	Patient-reported position of syncopes/malaises	standing, sitting, lying down	Baseline (Day 0)
Secondary	Patient-reported position of syncopes/malaises	standing, sitting, lying down	Yearly visit (month 12)
Secondary	Patient-reported sycope/malaise trigger	heat, crowding, pain, stress, effort, lack of sleep, none	Baseline (Day 0)
Secondary	Patient-reported sycope/malaise trigger	heat, crowding, pain, stress, effort, lack of sleep, none	Yearly visit (month 12)
Secondary	Patient-reported sycope/malaise timing	diurnal, nocturnal, postprandial, peri/post-miction/defecation	Baseline (Day 0)
Secondary	Patient-reported sycope/malaise timing	diurnal, nocturnal, postprandial, peri/post-miction/defecation	Yearly visit (month 12)
Secondary	Patient-reported frequency of signs preceding a loss of consciousness	always, sometimes, never	Baseline (Day 0)
Secondary	Patient-reported frequency of signs preceding a loss of consciousness	always, sometimes, never	Yearly visit (month 12)
Secondary	VAS for snoring	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for snoring	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for nocturnal agitation	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for nocturnal agitation	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for restless legs	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for restless legs	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for nycturia	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for nycturia	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for morning headaches	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for morning headaches	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for absence of libido	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for absence of libido	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for nocturnal sweating	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for nocturnal sweating	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for gastro-oesophagien reflux	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for gastro-oesophagien reflux	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for palpitations	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for palpitations	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	VAS for lack of concentration while driving	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Baseline (Day 0)
Secondary	VAS for lack of concentration while driving	Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).	Yearly visit (month 12)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Pichot's fatigue scale	This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue.	Baseline (Day 0)
Secondary	Pichot's fatigue scale	This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue.	Yearly visit (month 12)
Secondary	Pichot's depression inventory	This scale ranges from 0 to 13. Higher scores indicate more elements of depression.	Baseline (Day 0)
Secondary	Pichot's depression inventory	This scale ranges from 0 to 13. Higher scores indicate more elements of depression.	Yearly visit (month 12)
Secondary	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)
Secondary	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)