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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04022278
Other study ID # EXPLOSOM
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 16, 2022
Est. completion date March 16, 2022

Study information

Verified date March 2022
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 16, 2022
Est. primary completion date March 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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