Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)

Not Applicable

• Conditions: Hypertension Arterial
• Interventions: Other: Patient SAHOS sailed by the ventilation in PPC and not sailed; Other: Patient not SAHOS

• Registration Number: NCT03373357
• Lead Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre

Brief Summary

The MAPA is the reference method to estimate the PA during the SAHOS. The MAPA can be recommended over 48 hours: indeed, the PA falls at the beginning of every apnea then increases gradually up to a pressif peak arising at the time of the ventilatoire resumption. These variations arise under the influence of 4 stimulus: the désaturation in O2, the rise of the PaCO2, the increase of the respiratory effort and the microawakening of the end of apnea who are at the origin of a sympathetic stimulation.

Consequently a better diagnostic approach of the HTA (confirmation of a resistant HTA, an identification of the masked HTA and the patients " not dipper " by the MAPA), the identification of the SAHOS, and a better coverage) of the associated cardiovascular risk factors are essential and establish a stake in public health.

To investigator's knowledge, no datum or study on the association HTA-SAHOS and its consequences was until then realized in the French overseas departments.

Detailed Description

In Guadeloupe, data on the relationships between arterial hypertension and obstructive sleep apnea are unavailable. The aim of this study was: to assess the frequency of hypertension and non-dipper pattern evaluated by 48-hour ambulatory blood pressure monitoring in an adult population identified obstructive sleep apnea/non-obstructive sleep apnea during overnight polygraphy ; to determine the cardio-metabolic factors associated with obstructive sleep apnea.

Study Timeline

• Study Start: 2008-09-09
• Primary Completion: 2014-11-19
• Status Verified: 2017-12
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-08
• Last Update Submitted: 2017-12-08
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Patient suspected of SAHOS;
• Patient or third-party responsible for receiving information on the study and who signed informed consent ;
• Patient age over 18 years; Patient living in Guadeloupe.

Exclusion Criteria

• Patient non-affiliated to the social security scheme ;
• Patient with obstructive bronchopneumopathy, neuro-muscular pathology,
• central and mixed SAS, cardiac arrhythmia,
• systemic and chronic inflammatory syndrome ; -
• Pregnant and lactating patient ;
• patient in emergency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient SAHOS sailed by the ventilation in PPC and not sailed	Patient SAHOS sailed by the ventilation in PPC and not sailed	The patients who have a SAHOS sailed by the ventilation in PPC will be estimated and followed in 3 months then every 6 months by the investigators of the service of pneumology and the unity of cardiovascular explorations. The control of the material and its tolerance, the data supplied by the service providers (bodies of ventilation at home) will be estimated by the investigator of the service of pneumology. IDE the unity of cardiovascular explorations will plan and will realize a 2nd one MAPA after 3 months of ventilation in PPC.
Patient not SAHOS	Patient not SAHOS	The medical follow-up of patients no SAHOS will be assured by the investigators of the unity of cardiovascular explorations: phone consultation in 1 month, 3mois, then every 6 months, and an annual visit.

Primary Outcome Measures

Name	Time	Method
the frequency of hypertension	At the of the enrollment period, an average of 3 years", etc.).	The primary outcome measure the frequency of hypertension and non-dipper pattern evaluated by 48-hour ambulatory blood pressure monitoring in an adult population identified obstructive sleep apnea/non-obstructive sleep apnea during overnight polygraphy.

Secondary Outcome Measures

Name	Time	Method
The cardio-metabolic factors	"through study completion, an average of 8 years"	All the enrolled patients will be followed during 5 years and particularly concerning: * the appearance of new risk cardiovascular factors; * the advent of cardiovascular events

Trial Locations

Locations (1)

Hospital University Center of Pointe-à-Pitre; 🇬🇵 Pointe-à-Pitre, Guadeloupe