Pathophysiological Study of CSA in Adults With pLVEF (PHENOSAX)

  • STATUS
    Recruiting
  • End date
    Feb 2, 2025
  • participants needed
    45
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 20 April 2022
heart failure
polysomnography
collapse
obstructive sleep apnea
snoring

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.

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

Details
Condition Central Sleep Apnea
Treatment Critical airway closure pressure (Pcrit) measurment, Acoustic pharyngometry, High density surface electroencephalogram neural mapping
Clinical Study IdentifierNCT03919344
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

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
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