Syncope, VasovagalVVS-SASNCT04294524
Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS)
An observational study of Syncope, Vasovagal and Sleep Apnea Syndromes, run by PEAS (Pole d'Exploration des Apnees du Sommeil) at 8 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Vasovagal, Sleep Apnea Syndromes
- What is being tested?
- Sleep apnea treatment
- How many people
- 60 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 22 Feb 2017to 22 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The targeted study population consists of consecutive patients with both vasovagal syncope and sleep apnea syndrome with an indication for treatment.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
8 sites in 2 countries.
Isabelle Godard, MD contact
8 sites in 2 countries
France7 sites, 7 recruiting
- Recruiting
University Hospitals of Angers
Angers
Frédéric Gagnadou, MD
- Recruiting
Clinique Bel Air
Bordeaux
Vincent Puel, MD
Isabelle Godard, MD
- Recruiting
University Hospitals of Bordeaux
Bordeaux
Georgios Papaioannou, MD
Philippe Gosse, MD
- Recruiting
University Hospitals of Grenoble
Grenoble
Jean-Louis Pépin, MD
- Recruiting
Clinique Bouchard
Marseille
Fabrice Thoin, MD
- Recruiting
Public Assistance - Hospitals of Marseille
Marseille
Jean-Claude Deharo, MD
- Recruiting
University Hospitals of Saint Etienne
Saint-Etienne
Frédéric Roche, MD
Monaco1 site, 1 recruiting
- Recruiting
Princess Grace Hospital
Monaco
Naïma Zarqane, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Syncope, Vasovagal, Sleep Apnea Syndromes
- Being tested
- Sleep apnea treatment
- Medical subject headings
- Syncope, Vasovagal, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep apnea treatmentOther
Sleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month -6 to Day 0 versus Months +6 to +12
Secondary outcomes (41)
Syncope/malaise dates
Dates of syncopes/malaises throughout the study.
Measured: Day 0 to Month 12
Patient-reported syncope/malaise frequency
never, rare, every three months, every month, every week, several times per week
Measured: Baseline (Day 0)
Patient-reported syncope/malaise frequency
never, rare, every three months, every month, every week, several times per week
Measured: Yearly visit (month 12)
Patient-reported position of syncopes/malaises
standing, sitting, lying down
Measured: Baseline (Day 0)
Patient-reported position of syncopes/malaises
standing, sitting, lying down
Measured: Yearly visit (month 12)
Patient-reported sycope/malaise trigger
heat, crowding, pain, stress, effort, lack of sleep, none
Measured: Baseline (Day 0)
Patient-reported sycope/malaise trigger
heat, crowding, pain, stress, effort, lack of sleep, none
Measured: Yearly visit (month 12)
Patient-reported sycope/malaise timing
diurnal, nocturnal, postprandial, peri/post-miction/defecation
Measured: Baseline (Day 0)
Patient-reported sycope/malaise timing
diurnal, nocturnal, postprandial, peri/post-miction/defecation
Measured: Yearly visit (month 12)
Patient-reported frequency of signs preceding a loss of consciousness
always, sometimes, never
Measured: Baseline (Day 0)
Patient-reported frequency of signs preceding a loss of consciousness
always, sometimes, never
Measured: Yearly visit (month 12)
VAS for snoring
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for snoring
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for nocturnal agitation
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for nocturnal agitation
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for restless legs
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for restless legs
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for nycturia
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for nycturia
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for morning headaches
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for morning headaches
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for absence of libido
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for absence of libido
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for nocturnal sweating
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for nocturnal sweating
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for gastro-oesophagien reflux
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for gastro-oesophagien reflux
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for palpitations
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for palpitations
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Yearly visit (month 12)
VAS for lack of concentration while driving
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: Baseline (Day 0)
VAS for lack of concentration while driving
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Yearly visit (month 12)
Pichot's fatigue scale
This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue.
Measured: Baseline (Day 0)
Pichot's fatigue scale
This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue.
Measured: Yearly visit (month 12)
Pichot's depression inventory
This scale ranges from 0 to 13. Higher scores indicate more elements of depression.
Measured: Baseline (Day 0)
Pichot's depression inventory
This scale ranges from 0 to 13. Higher scores indicate more elements of depression.
Measured: 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.
Measured: 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.
Measured: Yearly visit (month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start22 Feb 2017
- Primary completion22 Feb 2022 (estimated)
- Study completion22 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PEAS (Pole d'Exploration des Apnees du Sommeil)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Puel, PEAS (Pole d'Exploration des Apnees du Sommeil)
- Investigators
- Vincent Puel, MD, Study director, Pôle d'exploration des apnées su sommeil (PEAS), Nouvelle Clinique Bel-Air - Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294524
- Sponsor's protocol ID
- 2017-A03169-44
- Other IDs
- 2017-A03169-44
- Acronym
- VVS-SAS
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32998925
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS): a Protocol for the VVS-SAS Registry Study
- ClinicalTrials.gov ID
- NCT04294524
- Acronym / sponsor ID
- VVS-SAS / 2017-A03169-44
- Conditions
- Syncope, Vasovagal, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PEAS (Pole d'Exploration des Apnees du Sommeil)University, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 22 Feb 2022 (estimated)
- Study completion
- 22 Feb 2022 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The targeted study population consists of consecutive patients with both vasovagal syncope and sleep apnea syndrome with an indication for treatment.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- Pathology that may explain syncope symptoms
- Cardiopathy
- Known disautonomia
- Hypotension of known origin
- Adrenal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep apnea treatmentSleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD). | Other | – |
Primary outcome
Change in 6-month syncope rate
Time frame: 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.
41 secondary outcomes
Syncope/malaise dates
Time frame: Day 0 to Month 12
Patient-reported syncope/malaise frequency
Time frame: Baseline (Day 0)
Patient-reported syncope/malaise frequency
Time frame: Yearly visit (month 12)
Patient-reported position of syncopes/malaises
Time frame: Baseline (Day 0)
Patient-reported position of syncopes/malaises
Time frame: Yearly visit (month 12)
Patient-reported sycope/malaise trigger
Time frame: Baseline (Day 0)
Patient-reported sycope/malaise trigger
Time frame: Yearly visit (month 12)
Patient-reported sycope/malaise timing
Time frame: Baseline (Day 0)
Patient-reported sycope/malaise timing
Time frame: Yearly visit (month 12)
Patient-reported frequency of signs preceding a loss of consciousness
Time frame: Baseline (Day 0)
Patient-reported frequency of signs preceding a loss of consciousness
Time frame: Yearly visit (month 12)
VAS for snoring
Time frame: Baseline (Day 0)
VAS for snoring
Time frame: Yearly visit (month 12)
VAS for nocturnal agitation
Time frame: Baseline (Day 0)
VAS for nocturnal agitation
Time frame: Yearly visit (month 12)
VAS for restless legs
Time frame: Baseline (Day 0)
VAS for restless legs
Time frame: Yearly visit (month 12)
VAS for nycturia
Time frame: Baseline (Day 0)
VAS for nycturia
Time frame: Yearly visit (month 12)
VAS for morning headaches
Time frame: Baseline (Day 0)
VAS for morning headaches
Time frame: Yearly visit (month 12)
VAS for absence of libido
Time frame: Baseline (Day 0)
VAS for absence of libido
Time frame: Yearly visit (month 12)
VAS for nocturnal sweating
Time frame: Baseline (Day 0)
VAS for nocturnal sweating
Time frame: Yearly visit (month 12)
VAS for gastro-oesophagien reflux
Time frame: Baseline (Day 0)
VAS for gastro-oesophagien reflux
Time frame: Yearly visit (month 12)
VAS for palpitations
Time frame: Baseline (Day 0)
VAS for palpitations
Time frame: Yearly visit (month 12)
VAS for lack of concentration while driving
Time frame: Baseline (Day 0)
VAS for lack of concentration while driving
Time frame: Yearly visit (month 12)
12-item Impact of Syncope on Quality of Life (ISQL) questionnaire
Time frame: Baseline (Day 0)
12-item Impact of Syncope on Quality of Life (ISQL) questionnaire
Time frame: Yearly visit (month 12)
the Epworth Sleepiness Scale
Time frame: Baseline (Day 0)
the Epworth Sleepiness Scale
Time frame: Yearly visit (month 12)
Pichot's fatigue scale
Time frame: Baseline (Day 0)
Pichot's fatigue scale
Time frame: Yearly visit (month 12)
Pichot's depression inventory
Time frame: Baseline (Day 0)
Pichot's depression inventory
Time frame: Yearly visit (month 12)
Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))
Time frame: Baseline (Day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 32998925Puel 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.
Related trials for Syncope, Vasovagal
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
Recruiting
Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial
Colorectal Neoplasia, Screening Colonoscopy
Active, not recruitingObservational study
A Warning Red Flag Classification System to Predict Risk of Vasovagal Event During Office Hysteroscopy
Vasovagal Syncope (VVS), Presyncope
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Godard, MD contact
Vincent Puel, MD study director
Pôle d'exploration des apnées su sommeil (PEAS), Nouvelle Clinique Bel-Air - Bordeaux
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, Vasovagal and Sleep Apnea Syndromes, run by PEAS (Pole d'Exploration des Apnees du Sommeil) at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Puel, MD (+33 557810587, vpuel001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-month syncope rate (time frame: Month -6 to Day 0 versus Months +6 to +12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.