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

Hypertension Arterial Clinical Trial

— HTA-SAHOS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03373357
• Other study ID #: RBM-PAP- 2007/19
• Status: Active, not recruiting
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 8, 2017
• Start date: September 9, 2008
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2017
• Source: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: November 30, 2019
• Est. primary completion date: November 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension Arterial
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Guadeloupe	Hospital University Center of Pointe-à-Pitre	Pointe-à-Pitre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Pointe-a-Pitre

Country where clinical trial is conducted

Guadeloupe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The cardio-metabolic factors	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	"through study completion, an average of 8 years"