Identify Patients at Risk of Moderate or Severe OSA During ENT Examination

NCT05808868 | Completed DMC

• 1 other identifier: 2021PI120
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Apnea Syndromes

Keywords

SAOS

Outcome Measures

Primary Outcomes (1)

• clinical sign and apnea/hypopnea index

  Measurement of the association between clinical signs assessed during the ENT examination and the sleep apnea hypopnea index

  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.

Study Arms (1)

OSA screening

To

Other: Screening

Interventions

Screening OTHER

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.

OSA screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \- 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

You may not qualify if:

• \- Patients with poor quality video recording of nasofibroscopy

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

LENAY Nicolas

Nancy, 54000, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• NGUYEN Duc Trung, PhD, M.P.H

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr NGUYEN Duc Trung - Hospital practitioner

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 12, 2023
• Study Start: May 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

FR (1)