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

Sleep Apnea Clinical Trial

— EXPLOSOM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04022278
• Other study ID #: EXPLOSOM
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

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