Sleep Apnea SyndromesNCT05808868
Identify Patients at Risk of Moderate or Severe OSA During ENT Examination
An observational study of Sleep Apnea Syndromes, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The management of OSA is multidisciplinary. Today, there are many self-evaluation questionnaires aiming at predicting or evaluating the severity of OSA. However, no clinical score takes into account the specificities of the ENT clinical examination, which is a major actor in the management of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Screening
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 1 Oct 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included correspond to the patients referred to the ENT consultation at the Nancy University Hospital for clinical screening of sleep apnea/hypopnea syndrome.
Who may be able to join
- Adult subjects (> 18 years old), referred to the ENT consultation of the Nancy University Hospital for ENT assessment in the context of OSA or suspicion of OSA, or consultation for the reason "snoring", or presenting clinical signs making OSA suspect.
- Non-inclusion criteria:
- Patients suspected of having another sleep disorder (indication for polysomnography)
- Patients with history of upper airway surgery or an ENT tumor
Who cannot join
- Patients with poor quality video recording of nasofibroscopy
Trial locations and contacts
1 site in 1 country.
About this study
The management of OSA is multidisciplinary. Today, there are many self-evaluation questionnaires aiming at predicting or evaluating the severity of OSA. However, no clinical score takes into account the specificities of the ENT clinical examination, which is a major actor in the management of the disease. The aim of this study is to create a clinical score predictive of the diagnosis and severity of OSA, using already published data, completed with the specificities of the ENT clinical examination.
Read the detailed description
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is defined as an alteration in nocturnal ventilation related to partial or complete collapse of the upper aerodigestive tract (UAD). The pharyngeal collapse responsible for nocturnal respiratory abnormalities is explained by three factors: anatomical narrowing of the upper airway, increased pharyngeal compliance and loss of efficiency of the pharyngeal dilator muscles. The prevalence of OSA has been estimated to be between 9% and 38%. However, OSA remains under-diagnosed. This syndrome leads, in the absence of treatment, to an overall excess mortality, particularly cardiovascular, and to numerous cardio-metabolic, neurological, psycho-social and road accident complications. Therefore, the identification of patients at risk of OSA through early and targeted screening becomes a public health issue in order to implement an effective treatment to reduce these complications.
VADS examination coupled with nasofibroscopy is a routine examination in ENT consultation. This examination can help to identify patients at risk of OSA and allow its pre-therapeutic evaluation, in order to define the patient's profile and personalize its management. The sites of VADS collapse are multiple. A systematic review on drug induced sleep endoscopy (DISE) found a distribution of obstructive sites of 58.8% for the soft palate, 43.2% for the base of the tongue, 29.9% for the lateral walls of the pharynx and 22.4% for the epiglottis. However, the laryngeal stage also plays a major role in the mechanism of OSA. Endoscopy under induced or natural sleep is a reliable method to identify obstructive sites. However, these techniques require important means (access to the operating room, dedicated hospital room), time, specific equipment and qualified personnel.
The standardized ENT clinical examination coupled with nasofibroscopy is inexpensive, rapid and easily accessible. It allows to identify patients at risk of OSA, to specify the obstructive sites in the VADS and to optimize the therapeutic management by differentiating the patients' profiles.
The objective of this study was to identify anatomical factors predictive of moderate/severe OSA on routine ENT examination in awake patients.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Screening
- Keywords
- SAOS
- 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.
ScreeningOther
The detailed management is not different from that usually practiced in our department.
Each patient benefits from an ENT consultation where an interrogation is carried out concerning the sleep disorders, the answer to the usual questionnaires screening for sleep disorders, a detailed ENT clinical examination including a nasofibroscopy. Each patient then benefits from a sleep recording by ventilatory polygraph.
| Study group | Role | What they receive |
|---|---|---|
| OSA screening | To Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical sign and apnea/hypopnea index
Measurement of the association between clinical signs assessed during the ENT examination and the sleep apnea hypopnea index
Measured: Statistical analyses are performed at the end of the recruitment period, when each patient has undergone a clinical examination and a ventilatory polygraph. Measurement date: October 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 May 2021
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duc Trung Nguyen, MD, PhD, Central Hospital, Nancy, France
- Investigators
- NGUYEN Duc Trung, PhD, M.P.H, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808868
- Sponsor's protocol ID
- 2021PI120
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lenay N, Toussaint B, Nguyen-Thi PL, Carpentier N, Nguyen DT. Identify Patients at Risk of Moderate or Severe OSAHS During ENT Examination. Laryngoscope Investig Otolaryngol. 2026 Jun 9;11(3):e70454. doi: 10.1002/lio2.70454. eCollection 2026 Jun.
PubMed 42281651
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify Patients at Risk of Moderate or Severe OSA During ENT Examination
- ClinicalTrials.gov ID
- NCT05808868
- Acronym / sponsor ID
- 2021PI120
- Conditions
- Sleep Apnea Syndromes
- Keywords
- SAOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 12 Apr 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.
The management of OSA is multidisciplinary. Today, there are many self-evaluation questionnaires aiming at predicting or evaluating the severity of OSA. However, no clinical score takes into account the specificities of the ENT clinical examination, which is a major actor in the management of the disease. The aim of this study is to create a clinical score predictive of the diagnosis and severity of OSA, using already published data, completed with the specificities of the ENT clinical examination.
Detailed description
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is defined as an alteration in nocturnal ventilation related to partial or complete collapse of the upper aerodigestive tract (UAD). The pharyngeal collapse responsible for nocturnal respiratory abnormalities is explained by three factors: anatomical narrowing of the upper airway, increased pharyngeal compliance and loss of efficiency of the pharyngeal dilator muscles. The prevalence of OSA has been estimated to be between 9% and 38%. However, OSA remains under-diagnosed. This syndrome leads, in the absence of treatment, to an overall excess mortality, particularly cardiovascular, and to numerous cardio-metabolic, neurological, psycho-social and road accident complications. Therefore, the identification of patients at risk of OSA through early and targeted screening becomes a public health issue in order to implement an effective treatment to reduce these complications.
VADS examination coupled with nasofibroscopy is a routine examination in ENT consultation. This examination can help to identify patients at risk of OSA and allow its pre-therapeutic evaluation, in order to define the patient's profile and personalize its management. The sites of VADS collapse are multiple. A systematic review on drug induced sleep endoscopy (DISE) found a distribution of obstructive sites of 58.8% for the soft palate, 43.2% for the base of the tongue, 29.9% for the lateral walls of the pharynx and 22.4% for the epiglottis. However, the laryngeal stage also plays a major role in the mechanism of OSA. Endoscopy under induced or natural sleep is a reliable method to identify obstructive sites. However, these techniques require important means (access to the operating room, dedicated hospital room), time, specific equipment and qualified personnel.
The standardized ENT clinical examination coupled with nasofibroscopy is inexpensive, rapid and easily accessible. It allows to identify patients at risk of OSA, to specify the obstructive sites in the VADS and to optimize the therapeutic management by differentiating the patients' profiles.
The objective of this study was to identify anatomical factors predictive of moderate/severe OSA on routine ENT examination in awake patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA screening | – | Other: ScreeningTo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included correspond to the patients referred to the ENT consultation at the Nancy University Hospital for clinical screening of sleep apnea/hypopnea syndrome.
Key inclusion criteria (4 listed)
- Adult subjects (> 18 years old), referred to the ENT consultation of the Nancy University Hospital for ENT assessment in the context of OSA or suspicion of OSA, or consultation for the reason "snoring", or presenting clinical signs making OSA suspect.
- Patients suspected of having another sleep disorder (indication for polysomnography)
- Patients with history of upper airway surgery or an ENT tumor
Key exclusion criteria (1 listed)
- Patients with poor quality video recording of nasofibroscopy
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 |
|---|---|---|
| ScreeningThe detailed management is not different from that usually practiced in our department. Each patient benefits from an ENT consultation where an interrogation is carried out concerning the sleep disorders, the answer to the usual questionnaires screening for sleep disorders, a detailed ENT clinical examination including a nasofibroscopy. Each patient then benefits from a sleep recording by ventilatory polygraph. | Other | OSA screening |
Primary outcome
clinical sign and apnea/hypopnea index
Time frame: Statistical analyses are performed at the end of the recruitment period, when each patient has undergone a clinical examination and a ventilatory polygraph. Measurement date: October 2022.
Measurement of the association between clinical signs assessed during the ENT examination and the sleep apnea hypopnea index
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 12 Apr 2023.
- Derived from this study: PubMed 42281651Lenay N, Toussaint B, Nguyen-Thi PL, Carpentier N, Nguyen DT. Identify Patients at Risk of Moderate or Severe OSAHS During ENT Examination. Laryngoscope Investig Otolaryngol. 2026 Jun 9;11(3):e70454. doi: 10.1002/lio2.70454. eCollection 2026 Jun.
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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.
NGUYEN Duc Trung, PhD, M.P.H principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, run by Central Hospital, Nancy, France 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 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 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?
clinical sign and apnea/hypopnea index (time frame: Statistical analyses are performed at the end of the recruitment period, when each patient has undergone a clinical examination and a ventilatory polygraph. Measurement date: October 2022.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808868, which also lists 1 linked publication.
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 12 Apr 2023.