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

NCT03373357 | Unknown DMC

• 1 other identifier: RBM-PAP- 2007/19
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension Arterial

Keywords

sleep apnea; arterial hypertension; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• the frequency of hypertension

  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.

  At the of the enrollment period, an average of 3 years", etc.).

Secondary Outcomes (1)

• The cardio-metabolic factors

  "through study completion, an average of 8 years"

Study Arms (2)

Patient not SAHOS

OTHER

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.

Other: Patient not SAHOS

Patient SAHOS sailed by the ventilation in PPC and not sailed

OTHER

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.

Other: Patient SAHOS sailed by the ventilation in PPC and not sailed

Interventions

Patient not SAHOS OTHER

Phone consultation in 1 month, 3mois, then every 6 months, and an annual visit. * Cardiovascular events arisen during the duration of the study * Modifications of the lifestyle: alcohol, physical activity * Weight * Clinical measure of the PA * Clinical examination * The collection of the cardiovascular events arisen during the duration of the study will be realized for all the inclusive patients

Patient not SAHOS

Patient SAHOS sailed by the ventilation in PPC and not sailed OTHER

Questionnaire of subjective evaluation of diurnal slumber: scale of Epworth and search for appearance of at least 2 of the following symptoms: sleep not salvage dealer, night-breathlessnesses, multiple awakenings, fatigue, disordersconfusions, nycturie, snore. * Questionnaire of evaluation of the global quality of life of the SAHOS * Appearance of new cardiovascular risk factors * Cardiovascular events arisen during the duration of the study * Modification of the current treatments * Modifications of the lifestyle: alcohol, physical activity * Weight * Clinical measure of the PA * Clinical examination * The collection of the cardiovascular events arisen during the duration of the study will be realized for all the inclusive patients

Patient SAHOS sailed by the ventilation in PPC and not sailed

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Hospital University Center of Pointe-à-Pitre

Pointe-à-Pitre, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Hypertension; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel BILLY BRISSAC, Dorctor cardiovascular

  Hospital University Center of Pointe-à-Pitre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All the patients will have sampling blood specific to the protocol: * Insulinémie * US CRP(TEACHERS' CENTRE) * Implementation of a sérothèque

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 14, 2017
• Study Start: September 9, 2008
• Primary Completion: November 19, 2014
• Study Completion: November 30, 2019
• Last Updated: December 14, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)