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

March 3, 2020 updated by: Vincent Puel, PEAS (Pole d'Exploration des Apnees du Sommeil)

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
          • Naima Zarqane, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Month -6 to Day 0 versus Months +6 to +12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Syncope/malaise dates
Time Frame: Day 0 to Month 12
Dates of syncopes/malaises throughout the study.
Day 0 to Month 12
Patient-reported syncope/malaise frequency
Time Frame: Baseline (Day 0)
never, rare, every three months, every month, every week, several times per week
Baseline (Day 0)
Patient-reported syncope/malaise frequency
Time Frame: Yearly visit (month 12)
never, rare, every three months, every month, every week, several times per week
Yearly visit (month 12)
Patient-reported position of syncopes/malaises
Time Frame: Baseline (Day 0)
standing, sitting, lying down
Baseline (Day 0)
Patient-reported position of syncopes/malaises
Time Frame: Yearly visit (month 12)
standing, sitting, lying down
Yearly visit (month 12)
Patient-reported sycope/malaise trigger
Time Frame: Baseline (Day 0)
heat, crowding, pain, stress, effort, lack of sleep, none
Baseline (Day 0)
Patient-reported sycope/malaise trigger
Time Frame: Yearly visit (month 12)
heat, crowding, pain, stress, effort, lack of sleep, none
Yearly visit (month 12)
Patient-reported sycope/malaise timing
Time Frame: Baseline (Day 0)
diurnal, nocturnal, postprandial, peri/post-miction/defecation
Baseline (Day 0)
Patient-reported sycope/malaise timing
Time Frame: Yearly visit (month 12)
diurnal, nocturnal, postprandial, peri/post-miction/defecation
Yearly visit (month 12)
Patient-reported frequency of signs preceding a loss of consciousness
Time Frame: Baseline (Day 0)
always, sometimes, never
Baseline (Day 0)
Patient-reported frequency of signs preceding a loss of consciousness
Time Frame: Yearly visit (month 12)
always, sometimes, never
Yearly visit (month 12)
VAS for snoring
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for snoring
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for nocturnal agitation
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for nocturnal agitation
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for restless legs
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for restless legs
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for nycturia
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for nycturia
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for morning headaches
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for morning headaches
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for absence of libido
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for absence of libido
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for nocturnal sweating
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for nocturnal sweating
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for gastro-oesophagien reflux
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for gastro-oesophagien reflux
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for palpitations
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for palpitations
Time Frame: Yearly visit (month 12)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Yearly visit (month 12)
VAS for lack of concentration while driving
Time Frame: Baseline (Day 0)
Visual analogue scale (VAS) ranging from 0 (no symptoms) to 10 (strongest symptoms).
Baseline (Day 0)
VAS for lack of concentration while driving
Time Frame: Yearly visit (month 12)
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
Time Frame: Baseline (Day 0)
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
Time Frame: 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.
Yearly visit (month 12)
the Epworth Sleepiness Scale
Time Frame: Baseline (Day 0)
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
Time Frame: Yearly visit (month 12)
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
Time Frame: Baseline (Day 0)
This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue.
Baseline (Day 0)
Pichot's fatigue scale
Time Frame: Yearly visit (month 12)
This scale describes fatigue and ranges from 0 to 32. Higher scores indicate more fatigue.
Yearly visit (month 12)
Pichot's depression inventory
Time Frame: Baseline (Day 0)
This scale ranges from 0 to 13. Higher scores indicate more elements of depression.
Baseline (Day 0)
Pichot's depression inventory
Time Frame: Yearly visit (month 12)
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))
Time Frame: Baseline (Day 0)
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))
Time Frame: Yearly visit (month 12)
The SF36 ranges from 0 to 100. Higher scores indicate higher quality of life.
Yearly visit (month 12)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The presence/absence of retrognathia
Time Frame: Baseline (Day 0)
This is a binary variable indicating qualitative presence or absence of a particular condition.
Baseline (Day 0)
The presence/absence of archival palate
Time Frame: Baseline (Day 0)
This is a binary variable indicating qualitative presence or absence of a particular condition.
Baseline (Day 0)
Mallampati score
Time Frame: Baseline (Day 0)
Baseline (Day 0)
The presence/absence of anterior open bite
Time Frame: Baseline (Day 0)
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
Time Frame: Baseline (Day 0)
This is a binary variable indicating qualitative presence or absence of a particular condition.
Baseline (Day 0)
Body mass index (kg/m2)
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Abdominal circumference (cm)
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Systolic blood pressure (mmHg) while lying down
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Systolic blood pressure (mmHg) while lying down after having remained in a standing position for 3 minutes
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Diastolic blood pressure (mmHg) while lying down
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Diastolic blood pressure (mmHg) after having remained in a standing position for 3 minutes
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Pulse (beats per minute) while lying down
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Pulse (beats per minute) after having remained in a standing position for 3 minutes
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Presence/absence of a positive table tilt test
Time Frame: Baseline (Day 0)
This is a binary variable indicating qualitative presence or absence of a particular condition.
Baseline (Day 0)
Haemoglobin (g/dl)
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Haematocrit (%)
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Blood thyroid stimulating hormone (microU/l)
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Blood sodium levels (mmol/l)
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Blood potassium levels (mmol/l)
Time Frame: Baseline (Day 0)
Baseline (Day 0)
Morning cortisol (mmol/l at 8 am)
Time Frame: Baseline (Day 0)
Baseline (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PEAS (Pole d'Exploration des Apnees du Sommeil)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vincent Puel, MD, Pôle d'exploration des apnées su sommeil (PEAS), Nouvelle Clinique Bel-Air - Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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