Pathophysiological Study of CSA in Adults With pLVEF

NCT03919344 | Terminated

• 1 other identifier: APHP 180442
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Upper airway collapsibility is assessed by Pcrit value in central leep apnea and snoring

  Pressure values of VAS (Pcrit) in patients in the "Central SAS" group and in the "Obstructive SAS" group

  1 day

Secondary Outcomes (6)

• Upper airway collapsibility is assessed by Pcrit value in central and obstructive sleep apnea

  1 day

• The association between Pcrit (cm H20) and Apnea-Hypopnoea Index (events/h)

  1 day

• Chemosensitivity in central sleep apnea is assessed by CO2 response test

  1 day

• Cardiorespiratory coupling in central sleep apnea is assessed by RR measurment (mm on EKG)

  1 day

• Neural network modifications in sleep apnea are assessed by frequency couplage indice

  1 day

Study Arms (3)

Central SAS cases

OTHER

Patients with central apnea

Other: Critical airway closure pressure (Pcrit) measurment; Other: Acoustic pharyngometry; Other: High density surface electroencephalogram neural mapping

Obstructive SAS controls

OTHER

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

Other: Critical airway closure pressure (Pcrit) measurment; Other: Acoustic pharyngometry

Snorers controls

OTHER

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

Other: Critical airway closure pressure (Pcrit) measurment; Other: Acoustic pharyngometry

Interventions

Critical airway closure pressure (Pcrit) measurment 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

Central SAS cases; Obstructive SAS controls; Snorers controls

Acoustic pharyngometry OTHER

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

Central SAS cases; Obstructive SAS controls; Snorers controls

High density surface electroencephalogram neural mapping OTHER

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

Central SAS cases

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Impossibility of giving the subject informed information
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marie-Pia D'ORTHO, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: April 18, 2019
• Study Start: February 2, 2021
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)