Back to results

Pathophysiological Study of CSA in Adults With pLVEF (PHENOSAX)

Primary Purpose

Central Sleep Apnea

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Critical airway closure pressure (Pcrit) measurment

Acoustic pharyngometry

High density surface electroencephalogram neural mapping

About this trial

This is an interventional other trial for Central Sleep Apnea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Bichat-Claude Bernard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Central SAS cases

Obstructive SAS controls

Snorers controls

Arm Description

Patients with central apnea

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Pcrit value in cm H20 in the obstructive SAS group vs. central SAS group

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

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

Chemosensitivity in central sleep apnea is assessed by CO2 response test

CO2 response slope (mL/min/mmHg) in CO2 response test via rebrething method

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

Parameters of cardiorespiratory coupling to polysomnography

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

Respiratory neural network mapping in patients with central SAS with preserved ejection fraction through high density mapping

Volume and collapsibility characteristics in acoustic pharyngometry in the different groups

Full Information

NCT ID

NCT03919344

First Posted

March 12, 2019

Last Updated

May 24, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT03919344

Brief Title

Pathophysiological Study of CSA in Adults With pLVEF

Acronym

PHENOSAX

Official Title

Pathophysiological Study of Central Sleep Apnea in Adults With Preserved LVEF

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

lack of inclusion

Study Start Date

February 2, 2021 (Actual)

Primary Completion Date

July 7, 2021 (Actual)

Study Completion Date

July 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Sleep Apnea

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Central SAS cases

Arm Type

Other

Arm Description

Patients with central apnea

Arm Title

Obstructive SAS controls

Arm Type

Other

Arm Description

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

Arm Title

Snorers controls

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Critical airway closure pressure (Pcrit) measurment

Intervention Description

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

Intervention Name(s)

Acoustic pharyngometry

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

High density surface electroencephalogram neural mapping

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 day

Secondary Outcome Measure Information:

Title

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

Description

Pcrit value in cm H20 in the obstructive SAS group vs. central SAS group

Time Frame

1 day

Title

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

Description

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

Time Frame

1 day

Title

Chemosensitivity in central sleep apnea is assessed by CO2 response test

Description

CO2 response slope (mL/min/mmHg) in CO2 response test via rebrething method

Time Frame

1 day

Title

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

Description

Parameters of cardiorespiratory coupling to polysomnography

Time Frame

1 day

Title

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

Description

Respiratory neural network mapping in patients with central SAS with preserved ejection fraction through high density mapping

Time Frame

1 day

Title

Volume and collapsibility characteristics in acoustic pharyngometry in the different groups

Time Frame

1 day

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie-Pia D'ORTHO, Professor

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Bichat-Claude Bernard

City

Paris

ZIP/Postal Code

75018

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pathophysiological Study of CSA in Adults With pLVEF

We'll reach out to this number within 24 hrs