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

Primary Purpose

Hypertension Arterial

Status
Unknown status
Phase
Not Applicable
Locations
Guadeloupe
Study Type
Interventional
Intervention
Patient not SAHOS
Patient SAHOS sailed by the ventilation in PPC and not sailed
Sponsored by
Centre Hospitalier Universitaire de Pointe-a-Pitre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension Arterial focused on measuring sleep apnea, arterial hypertension, cardiovascular risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital University Center of Pointe-à-Pitre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient not SAHOS

Patient SAHOS sailed by the ventilation in PPC and not sailed

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2017
Last Updated
December 8, 2017
Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
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1. Study Identification

Unique Protocol Identification Number
NCT03373357
Brief Title
Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)
Acronym
HTA-SAHOS
Official Title
Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2008 (Actual)
Primary Completion Date
November 19, 2014 (Actual)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension Arterial
Keywords
sleep apnea, arterial hypertension, cardiovascular risk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All the patients will have sampling blood specific to the protocol: Insulinémie US CRP(TEACHERS' CENTRE) Implementation of a sérothèque
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient not SAHOS
Arm Type
Other
Arm Description
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.
Arm Title
Patient SAHOS sailed by the ventilation in PPC and not sailed
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Patient not SAHOS
Intervention Description
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
Intervention Name(s)
Patient SAHOS sailed by the ventilation in PPC and not sailed
Intervention Description
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
Primary Outcome Measure Information:
Title
the frequency of hypertension
Description
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.
Time Frame
At the of the enrollment period, an average of 3 years", etc.).
Secondary Outcome Measure Information:
Title
The cardio-metabolic factors
Description
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
Time Frame
"through study completion, an average of 8 years"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel BILLY BRISSAC, Dorctor cardiovascular
Organizational Affiliation
Hospital University Center of Pointe-à-Pitre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital University Center of Pointe-à-Pitre
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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