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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
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Other

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

First Posted
March 12, 2019
Last Updated
May 24, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
No

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Pathophysiological Study of CSA in Adults With pLVEF

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