Central Sleep ApneaPHENOSAXNCT03919344
Pathophysiological Study of CSA in Adults With pLVEF
A study testing Critical airway closure pressure (Pcrit) measurment, Acoustic pharyngometry and High density surface electroencephalogram neural mapping in people with Central Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Central Sleep Apnea
- What is being tested?
- Critical airway closure pressure (Pcrit) measurment, Acoustic pharyngometry and High density surface electroencephalogram neural mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathophysiological Study of Central Sleep Apnea in Adults With Preserved LVEF
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.
Read the 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
- Being tested
- Critical airway closure pressure (Pcrit) measurment, Acoustic pharyngometry, High density surface electroencephalogram neural mapping
- Medical subject headings
- Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical airway closure pressure (Pcrit) measurmentOther
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 pharyngometryOther
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 mappingOther
Mapping of the respiratory neural network will allow us to study the areas of the brain activated during breathing
| Study group | Role | What they receive |
|---|---|---|
| Central SAS cases | Other | Patients with central apnea Receives: 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) Receives: 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) Receives: Other: Critical airway closure pressure (Pcrit) measurment; Other: Acoustic pharyngometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (6)
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
Measured: 1 day
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)
Measured: 1 day
Chemosensitivity in central sleep apnea is assessed by CO2 response test
CO2 response slope (mL/min/mmHg) in CO2 response test via rebrething method
Measured: 1 day
Cardiorespiratory coupling in central sleep apnea is assessed by RR measurment (mm on EKG)
Parameters of cardiorespiratory coupling to polysomnography
Measured: 1 day
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
Measured: 1 day
Volume and collapsibility characteristics in acoustic pharyngometry in the different groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start2 Feb 2021
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Pia D'ORTHO, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919344
- Sponsor's protocol ID
- APHP 180442
- Acronym
- PHENOSAX
- Status last verified
- May 2023
- First submitted
- 12 Mar 2019
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Study of Central Sleep Apnea in Adults With Preserved LVEF
- ClinicalTrials.gov ID
- NCT03919344
- Acronym / sponsor ID
- PHENOSAX / APHP 180442
- Conditions
- Central Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Central SAS cases | Other | Other: Critical airway closure pressure (Pcrit) measurment, Other: Acoustic pharyngometry, Other: High density surface electroencephalogram neural mappingPatients with central apnea |
| Obstructive SAS controls | Other | Other: Critical airway closure pressure (Pcrit) measurment, Other: Acoustic pharyngometryPatients with moderate to severe obstructive apnea (apnea-hypopnoea index ≥ 15 / h) |
| Snorers controls | Other | Other: Critical airway closure pressure (Pcrit) measurment, Other: Acoustic pharyngometrySnorers controls : Patients with snoring, with or without mild obstructive apneas (index of apnea-hypopneas <15 / h) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical airway closure pressure (Pcrit) measurmentPcrit 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 | Other | Central SAS cases, Obstructive SAS controls, Snorers controls |
| Acoustic pharyngometryAcoustic pharyngometry will assess the volume of the pharynx and determine if there is an obstacle in the upper airways. | Other | Central SAS cases, Obstructive SAS controls, Snorers controls |
| High density surface electroencephalogram neural mappingMapping of the respiratory neural network will allow us to study the areas of the brain activated during breathing | Other | Central SAS cases |
Primary outcome
Upper airway collapsibility is assessed by Pcrit value in central leep apnea and snoring
Time frame: 1 day
Pressure values of VAS (Pcrit) in patients in the "Central SAS" group and in the "Obstructive SAS" group
6 secondary outcomes
Upper airway collapsibility is assessed by Pcrit value in central and obstructive sleep apnea
Time frame: 1 day
The association between Pcrit (cm H20) and Apnea-Hypopnoea Index (events/h)
Time frame: 1 day
Chemosensitivity in central sleep apnea is assessed by CO2 response test
Time frame: 1 day
Cardiorespiratory coupling in central sleep apnea is assessed by RR measurment (mm on EKG)
Time frame: 1 day
Neural network modifications in sleep apnea are assessed by frequency couplage indice
Time frame: 1 day
Volume and collapsibility characteristics in acoustic pharyngometry in the different groups
Time frame: 1 day
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
Related trials for Central Sleep Apnea
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Myofunctional Therapy for Children With OSA
Obstructive Sleep Apnea (OSA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Pia D'ORTHO, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical airway closure pressure (Pcrit) measurment, Acoustic pharyngometry and High density surface electroencephalogram neural mapping in people with Central Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper airway collapsibility is assessed by Pcrit value in central leep apnea and snoring (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.