Cross-sectional Study on a Given Day Within the Paris Saint-Joseph Hospital Group (EXPLOSOM)

Evaluation of the Population Likely to Benefit From Sleep Exploration: Cross-sectional Study on a Given Day Within the Paris Saint-Joseph Hospital Group

Sleep apnea syndrome has an estimated incidence of 2 to 4% in the adult population and more so in men and with aging. It is an independent risk factor for mortality. Cardiovascular pathologies, diabetes, and stroke are known comorbidities with a high rate of association. There is no recommendation to screen these patients although the interest is assumed and sleep apnea syndrome is largely underdiagnosed. Interrogation and clinical examination guide but they are neither sensitive nor specific. The use of scores improves screening. In the general population, the Berlin score has a high false negative rate. The STOP-BANG score is sensitive but with a poor positive predictive value. Combined, these scores can be used to detect Sleep Apnea Syndrome. The interest of a management was especially shown for the very symptomatic syndromes because it is a pledge of observance of the treatment, itself necessary for the effectiveness in the prevention of the cardiovascular complications.

Study Overview

• Status: Withdrawn
• Conditions: Sleep Apnea

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient hospitalized on the day of the survey in any of the services of the cardio-neurovascular division of the Paris Saint-Joseph Hospital Group, whatever the history of comorbidities, the reason for hospitalization

Description

Inclusion Criteria:

• Patient whose age is> 18 years
• Any patient hospitalized on the day of the survey in any of the services of the cardio-neurovascular division of the Paris Saint-Joseph Hospital Group, whatever the history of comorbidities, the reason for hospitalization
• Francophone patient

Exclusion Criteria:

• Patient under tutorship or curatorship
• Patient deprived of liberty
• Patient at the end of life
• Patient opposing his participation in the research protocol

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients with severe co-morbidities whose clinical presentation suggests sleep apnea syndrome sufficiently severe and symptomatic to benefit from sleep exploration	This outcome measure the roportion of patients with all of the criteria defining the patient as "comorbid and symptomatic suspect".	Day 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Claire P GAZANIOL, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: EXPLOSOM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No