MedDataX Logo

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

NCT ID: NCT03373357

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-09

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Arterial

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sleep apnea arterial hypertension cardiovascular risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All the patients will have sampling blood specific to the protocol:

* Insulinémie
* US CRP(TEACHERS' CENTRE)
* Implementation of a sérothèque
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Patient not SAHOS

Intervention Type 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 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.

Group Type OTHER

Patient SAHOS sailed by the ventilation in PPC and not sailed

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patient not SAHOS

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

Intervention Type OTHER

Patient SAHOS sailed by the ventilation in PPC and not sailed

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rachel BILLY BRISSAC, Dorctor cardiovascular

Role: PRINCIPAL_INVESTIGATOR

Hospital University Center of Pointe-à-Pitre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital University Center of Pointe-à-Pitre

Pointe-à-Pitre, , Guadeloupe

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Guadeloupe

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RBM-PAP- 2007/19

Identifier Type: -

Identifier Source: org_study_id