Pathophysiological Study of CSA in Adults With pLVEF

NCT ID: NCT03919344

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2021-07-07

Brief Summary

Sleep apnea is classically divided into obstructive and central apnea, according to the persistence or otherwise of respiratory movements and the existence or not of pharyngeal collapse during apnea. However, there is evidence to suggest that some mechanisms are common to both types of apnea. Although the pathophysiology of obstructive apnea has been the subject of much work and now seems fairly well known, there is much less data on central apnea. These apneas can occur in different comorbid contexts. They are more frequently present in patients with heart failure, regardless of the etiology, and are associated with an adverse prognosis. The investigators hypothesize that the physiopathology of adult central apnea syndrome involves, in addition to ventilatory control abnormalities, upper airway abnormalities (VAS). The objective is to study the pathophysiology of central SAS, by first comparing the collapse of VAS of central apneic patients to those of patients with simple snoring or obstructive sleep apnea. In a second step, the investigators will analyze the cardiorespiratory coupling and will establish a map of the respiratory neural network in patients with central apnea. The investigators will focus their study on patients with central SAS (with preserved systolic heart function) due to the epidemiology of SAS.

Detailed Description

A non-randomized case-control comparative monocentric physiopathology study with 3 parallel groups (one group of cases and two control groups) matched for age and body mass index (individual 1: 1: 1 match), to evaluate changes in the collapse of VAS in central apnea ("central SAS case"), compared to subjects without central apnea ("obstructive SAS" and "single snoring").

Primary objective : Evaluation of changes in upper airway collapse in patients with central sleep apnea syndrome with preserved LVEF heart failure ("central SAS case"), compared with snoring subjects free from sleep apnea syndrome ("Simple snoring witnesses")

Secondary objectives :

• Study the collapsibility of VAS according to the type of apnea ("central SAS case" versus "obstructive SAS case").
• To study the association between the collapsibility of VAS and the global and central apnea-hypopnoea index (IAH).
• Study the association between the type of disorder ("central SAS case" versus "simple snoring controls", "central SAS case" versus "obstructive SAS controls") and cardiorespiratory coupling.
• Study the association between the type of disorder ("central SAS case" versus "simple snoring controls", "central SAS case" versus "obstructive SAS controls") and the CO2 response slope.
• Establish a map of the respiratory neural network in patients with central SAS with preserved ejection fraction.
• Study the association between the volumes in acoustic pharyngometry and the values of the Pcrit

Conditions

Central Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Central SAS cases

Patients with central apnea

Group Type: OTHER

Critical airway closure pressure (Pcrit) measurment

Intervention Type: OTHER

Pcrit is measured in awake patient, by applying a gradually decreasing pressure through a nasal NIV mask. Pcrit is defined as the pressure inducing airflow cessation in upper airway

Acoustic pharyngometry

Intervention Type: OTHER

Acoustic pharyngometry will assess the volume of the pharynx and determine if there is an obstacle in the upper airways.

High density surface electroencephalogram neural mapping

Intervention Type: OTHER

Mapping of the respiratory neural network will allow us to study the areas of the brain activated during breathing

Obstructive SAS controls

Patients with moderate to severe obstructive apnea (apnea-hypopnoea index ≥ 15 / h)

Group Type: OTHER

Critical airway closure pressure (Pcrit) measurment

Intervention Type: OTHER

Pcrit is measured in awake patient, by applying a gradually decreasing pressure through a nasal NIV mask. Pcrit is defined as the pressure inducing airflow cessation in upper airway

Acoustic pharyngometry

Intervention Type: OTHER

Acoustic pharyngometry will assess the volume of the pharynx and determine if there is an obstacle in the upper airways.

Snorers controls

Snorers controls : Patients with snoring, with or without mild obstructive apneas (index of apnea-hypopneas \<15 / h)

Group Type: OTHER

Critical airway closure pressure (Pcrit) measurment

Intervention Type: OTHER

Pcrit is measured in awake patient, by applying a gradually decreasing pressure through a nasal NIV mask. Pcrit is defined as the pressure inducing airflow cessation in upper airway

Acoustic pharyngometry

Intervention Type: OTHER

Acoustic pharyngometry will assess the volume of the pharynx and determine if there is an obstacle in the upper airways.

Interventions

Critical airway closure pressure (Pcrit) measurment

Pcrit is measured in awake patient, by applying a gradually decreasing pressure through a nasal NIV mask. Pcrit is defined as the pressure inducing airflow cessation in upper airway

Intervention Type: OTHER

Acoustic pharyngometry

Acoustic pharyngometry will assess the volume of the pharynx and determine if there is an obstacle in the upper airways.

Intervention Type: OTHER

High density surface electroencephalogram neural mapping

Mapping of the respiratory neural network will allow us to study the areas of the brain activated during breathing

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male patient
• Age ≥18 years and ≤85 years
• With preserved LVEF heart failure (defined as LVEF ≥ 45% on ultrasound, MRI or isotopic ventriculography)
• Central SAS Group: Central to severe sleep apnea syndrome, defined by an apnea-hypopnoea index (IAH) greater than 15 per hour, of which at least 30% are central events;
• Obstructive SAS group: Moderate to severe obstructive sleep apnea syndrome, defined by an apnea-hypopnoea index (IAH) greater than 15 per hour, with a central event proportion of less than 30%
• Group "snoring": absence of sleep apnea syndrome or mild sleep apnea syndrome (IAH <15 / h) in polysomnography, and presence of snoring on at least 30% of the night of recording.
• Free, informed and written consent
• Patient affiliated to a social security scheme (beneficiary or beneficiary)

Exclusion Criteria

• Impossibility of giving the subject informed information
• Participation in a research protocol involving the human person in the previous months if an exclusion directive is given in this protocol
• Use of respiratory or sedative depressant drugs, systemic corticosteroid therapy
• Impaired systolic function (defined by LVEF <45% in ultrasound, MRI or isotopic ventriculography)
• Unstable cardiovascular disease (cardiovascular event of less than one month)
• Recent surgery of the ENT sphere (less than 6 months)
• Central neurological pathology known
• Known, severe respiratory pathology (severity left to the investigator's discretion)
• Renal insufficiency (creatinine clearance <60 mL / min) or severe hepatic impairment
• Primary or secondary hemostasis disorder
• Patient on anticoagulant (antivitamin K, direct oral anticoagulant, heparin and related). Antiplatelet agents are allowed.
• Psychiatric pathology according to DSM-V criteria, unbalanced
• Pulsed saturation with oxyhemoglobin <88% at rest, on awakening
• Allergy to lidocaine
• Patient under tutorship or curatorship
• Failure to perform a prior medical examination
• Tympanic perforation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Pia D'ORTHO, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat-Claude Bernard

Paris, , France

Countries

France

Other Identifiers

APHP 180442

Identifier Type: -

Identifier Source: org_study_id