Sleep Apnea SyndromesP3ENCT05774522
Study of Anatomo-functional Correlation of the Upper Airways
A study testing Measurement of pharyngeal critical airway closing pressure, Acoustic pharyngometry and Upper airway ultrasound in people with Sleep Apnea Syndromes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sleep apnea-hypopnea syndrome (SAHS) is a disorder of nocturnal ventilation due to the occurrence abnormally frequent pauses in breathing. It is a public health problem that currently affects 13 % of men and 6% of women between 30 and 70 years old. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Measurement of pharyngeal critical airway closing pressure, Acoustic pharyngometry and Upper airway ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2023to 31 Jul 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: - Any patient, consulting the sleep department of the Bichat hospital for suspected sleep apnea syndrome
- Patient for whom an PSG are prescribed as part of care
- Age ≥18 years and ≤85 years Exclusion criteria: - Recent ENT surgery (less than 6 months)
- Pregnancy in progress (declared)
- Pulsed oxyhaemoglobin saturation < 88% at rest on awakening
- Allergy to ultrasound gel
- Patient with difficulties in understanding the French language
- Vulnerable patient (guardianship, curators)
- Lack of affiliation to a social security scheme
- Lack of information and collection of informed, written and signed consent
- Patient under AME
Trial locations and contacts
1 site in 1 country.
About this study
Sleep apnea-hypopnea syndrome (SAHS) is a disorder of nocturnal ventilation due to the occurrence abnormally frequent pauses in breathing. It is a public health problem that currently affects 13 % of men and 6% of women between 30 and 70 years old. Sleep apneas are conventionally divided into obstructive and central apneas, depending on the persistence or no respiratory movements and the existence or not pharyngeal collapse during apnea. There are upper airway characterization studies (VAS) in patients with syndrome sleep apnea/hypopnea (OSAS). These physiological characterization studies (measurement of critical closing pressure (Pcrit) of the VAS) and anatomical (transcutaneous ultrasound of the muscles of the floor of the mouth, the base of the tongue, or by a acoustic pharyngometry of the VAS) are interested separately to different parameters without searching correlation with the severity of sleep apnea nor their potential as a screening tool for OSAS in patients at risk. The investigators hypothesize that a strong correlation and constant exists between the physiological collapsibility of VAS, the anatomical measurements of the VAS and the degree of severity of OSAS. Thus, the aim of this descriptive study is to characterization as complete as possible of the VAS of apneic patients in a homogeneous population and a better understanding of the pathophysiological obstructive events in patients without factor obvious risk.
Read the detailed description
Obstructive sleep apnea-hypopnea syndrome (OSAS) is a nocturnal respiratory disorder caused by a succession of respiratory pauses. The prevalence of OSAHS has increased over the past two decades partly due to the fact that it is more often diagnosed but also due to the progression of obesity. It now affects 13% of men and 6% of women between the ages of 30 and 70. Sleep apneas are conventionally divided into obstructive and central apneas, depending on whether or not respiratory movements persist and whether or not there is pharyngeal collapse during the apnea. Continuous positive airway pressure (CPAP) ventilation via a nasal or naso-buccal mask is the reference treatment. The effectiveness of CPAP is directly linked to its observance. A well conducted treatment allows a significant improvement of symptoms related to OSAHS and effectively reduces daytime sleepiness. In the longer term, it would provide protection against cardiovascular events.
The physiopathology of obstructive apnea has been the subject of in-depth studies; the most recent data show that it is a multifactorial disease. Among the factors implicated, the investigators can cite pharyngeal anomalies (anatomy and collapsibility), a significant ventilatory response ("high loop gain") in response to variations in partial pressure of CO2 (pCO2), a weak pharyngeal muscle response during sleep and a high wakefulness threshold. Each of them can be evaluated by different methods: anatomy by a standardized clinical examination and imaging techniques, some of which have not yet been the subject of anatomo-functional correlation studies (such as the ultrasound or acoustic pharyngometry); collapsibility by measuring the critical closure pressure (Pcrit) (pressure applied at which closure of the airways is observed); the ventilatory response by analysis of the SpO2 and PCO2 signals in the exhaled air (PETCO2) in calm ventilation and ventilatory slope of response to hypercapnia; pharyngeal electromyogram and polysomnographic analysis.
The respective importance of these factors seems to vary greatly from one individual to another, but their characterization would make it possible to propose new avenues of treatment targeting the "loop gain", the pharyngeal muscle tone or the arousal threshold, and d adapt these targets to each patient for a personalized treatment.
The investigators hypothesize that a correlation exists between the physiological collapsibility of the VAS, the anatomical measurements of the VAS and the degree of severity of OSAHS. The objectives of our study are to identify clinical and physiological phenotypes of apneic patients, with the prospect of screening tools, a better distribution of targeted diagnostic and therapeutic resources.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Measurement of pharyngeal critical airway closing pressure, Acoustic pharyngometry, Upper airway ultrasound
- Keywords
- sleep apnea syndrome, upper airway, pCrit, acoustic pharyngometry, upper airway ultrasound
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of pharyngeal critical airway closing pressureOther
Also called pCrit
The Pcrit will be measured on an automatic controlled device specially designed by the engineers of the inserm neophen team capable of varying the pressures from +4 to -20 centimeters of water, by a nasal mask whose pressures are connected to a pneumotachograph. The measurements will be performed in supine position.
Acoustic pharyngometryOther
Acoustic pharyngometry is an non-invasive technique consisting of the propagation of an acoustic wave from the lips to the larynx providing information on the lengths, cross-sectional areas and volumes of the air spaces.
Upper airway ultrasoundOther
Airway ultrasound is a non-invasive imaging allowing visualization and measurements of the tongue base and retrovascular fatty infiltration. Its main interest remains the evaluation of the tongue base which is clinically difficult.
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of sleep apnea syndrome | Experimental | All patients, consulting Bichat sleep center for suspected sleep apnea syndrome Receives: Other: Measurement of pharyngeal critical airway closing pressure; Other: Acoustic pharyngometry; Other: Upper airway ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of the values of critical closing pressure of the upper airway
Measured: during procedure
The measurements in cm of tissus thickness of the upper airways by ultrasound
Measured: during procedure
measure the cross-sectional area of the upper airway by a acoustic pharyngometry
Measured: during procedure
Secondary outcomes (5)
measure of pharyngeal volume by ultrasound
Measured: during procedure
measure of pharyngeal collapsibility by ultrasound
Measured: during procedure
predictive value (Sp, Se) of acoustic pharyngometry measurements
Measured: during procedure
predictive value of ultrasound measurements (Sp, Se)
Measured: during procedure
measure of apnea hypopnea index by polysomnography
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start7 Feb 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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, MD. Ph.D, Principal investigator, Assistance Publique - Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774522
- Sponsor's protocol ID
- APHP220939
- Other IDs
- 2022-A01754-39
- Acronym
- P3E
- Status last verified
- Aug 2023
- First submitted
- 22 Feb 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anatomo-functional Correlation of the Upper Airways
- ClinicalTrials.gov ID
- NCT05774522
- Acronym / sponsor ID
- P3E / APHP220939
- Conditions
- Sleep Apnea Syndromes
- Keywords
- sleep apnea syndrome, upper airway, pCrit, acoustic pharyngometry, upper airway ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 17 Mar 2023 (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-hypopnea syndrome (SAHS) is a disorder of nocturnal ventilation due to the occurrence abnormally frequent pauses in breathing. It is a public health problem that currently affects 13 % of men and 6% of women between 30 and 70 years old. Sleep apneas are conventionally divided into obstructive and central apneas, depending on the persistence or no respiratory movements and the existence or not pharyngeal collapse during apnea. There are upper airway characterization studies (VAS) in patients with syndrome sleep apnea/hypopnea (OSAS). These physiological characterization studies (measurement of critical closing pressure (Pcrit) of the VAS) and anatomical (transcutaneous ultrasound of the muscles of the floor of the mouth, the base of the tongue, or by a acoustic pharyngometry of the VAS) are interested separately to different parameters without searching correlation with the severity of sleep apnea nor their potential as a screening tool for OSAS in patients at risk. The investigators hypothesize that a strong correlation and constant exists between the physiological collapsibility of VAS, the anatomical measurements of the VAS and the degree of severity of OSAS. Thus, the aim of this descriptive study is to characterization as complete as possible of the VAS of apneic patients in a homogeneous population and a better understanding of the pathophysiological obstructive events in patients without factor obvious risk.
Detailed description
Obstructive sleep apnea-hypopnea syndrome (OSAS) is a nocturnal respiratory disorder caused by a succession of respiratory pauses. The prevalence of OSAHS has increased over the past two decades partly due to the fact that it is more often diagnosed but also due to the progression of obesity. It now affects 13% of men and 6% of women between the ages of 30 and 70. Sleep apneas are conventionally divided into obstructive and central apneas, depending on whether or not respiratory movements persist and whether or not there is pharyngeal collapse during the apnea. Continuous positive airway pressure (CPAP) ventilation via a nasal or naso-buccal mask is the reference treatment. The effectiveness of CPAP is directly linked to its observance. A well conducted treatment allows a significant improvement of symptoms related to OSAHS and effectively reduces daytime sleepiness. In the longer term, it would provide protection against cardiovascular events.
The physiopathology of obstructive apnea has been the subject of in-depth studies; the most recent data show that it is a multifactorial disease. Among the factors implicated, the investigators can cite pharyngeal anomalies (anatomy and collapsibility), a significant ventilatory response ("high loop gain") in response to variations in partial pressure of CO2 (pCO2), a weak pharyngeal muscle response during sleep and a high wakefulness threshold. Each of them can be evaluated by different methods: anatomy by a standardized clinical examination and imaging techniques, some of which have not yet been the subject of anatomo-functional correlation studies (such as the ultrasound or acoustic pharyngometry); collapsibility by measuring the critical closure pressure (Pcrit) (pressure applied at which closure of the airways is observed); the ventilatory response by analysis of the SpO2 and PCO2 signals in the exhaled air (PETCO2) in calm ventilation and ventilatory slope of response to hypercapnia; pharyngeal electromyogram and polysomnographic analysis.
The respective importance of these factors seems to vary greatly from one individual to another, but their characterization would make it possible to propose new avenues of treatment targeting the "loop gain", the pharyngeal muscle tone or the arousal threshold, and d adapt these targets to each patient for a personalized treatment.
The investigators hypothesize that a correlation exists between the physiological collapsibility of the VAS, the anatomical measurements of the VAS and the degree of severity of OSAHS. The objectives of our study are to identify clinical and physiological phenotypes of apneic patients, with the prospect of screening tools, a better distribution of targeted diagnostic and therapeutic resources.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of sleep apnea syndrome | Experimental | Other: Measurement of pharyngeal critical airway closing pressure, Other: Acoustic pharyngometry, Other: Upper airway ultrasoundAll patients, consulting Bichat sleep center for suspected sleep apnea syndrome |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Measurement of pharyngeal critical airway closing pressureAlso: pCritThe Pcrit will be measured on an automatic controlled device specially designed by the engineers of the inserm neophen team capable of varying the pressures from +4 to -20 centimeters of water, by a nasal mask whose pressures are connected to a pneumotachograph. The measurements will be performed in supine position. | Other | Suspicion of sleep apnea syndrome |
| Acoustic pharyngometryAcoustic pharyngometry is an non-invasive technique consisting of the propagation of an acoustic wave from the lips to the larynx providing information on the lengths, cross-sectional areas and volumes of the air spaces. | Other | Suspicion of sleep apnea syndrome |
| Upper airway ultrasoundAirway ultrasound is a non-invasive imaging allowing visualization and measurements of the tongue base and retrovascular fatty infiltration. Its main interest remains the evaluation of the tongue base which is clinically difficult. | Other | Suspicion of sleep apnea syndrome |
Primary outcome
measure of the values of critical closing pressure of the upper airway
Time frame: during procedure
The measurements in cm of tissus thickness of the upper airways by ultrasound
Time frame: during procedure
measure the cross-sectional area of the upper airway by a acoustic pharyngometry
Time frame: during procedure
5 secondary outcomes
measure of pharyngeal volume by ultrasound
Time frame: during procedure
measure of pharyngeal collapsibility by ultrasound
Time frame: during procedure
predictive value (Sp, Se) of acoustic pharyngometry measurements
Time frame: during procedure
predictive value of ultrasound measurements (Sp, Se)
Time frame: during procedure
measure of apnea hypopnea index by polysomnography
Time frame: during procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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, MD. Ph.D principal investigator
Assistance Publique - Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of pharyngeal critical airway closing pressure, Acoustic pharyngometry and Upper airway ultrasound in people with Sleep Apnea Syndromes, 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?
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: finished, as of the sponsor's last update on 11 Aug 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measure of the values of critical closing pressure of the upper airway (time frame: during procedure). The study lists 3 primary outcomes in all. 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 11 Aug 2026.