Hypertension ArterialHTA-SAHOSNCT03373357
Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)
A study testing Patient not SAHOS and Patient SAHOS sailed by the ventilation in PPC and not sailed in people with Hypertension Arterial, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension Arterial
- What is being tested?
- Patient not SAHOS and Patient SAHOS sailed by the ventilation in PPC and not sailed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 9 Sep 2008to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
Hospital University Center of Pointe-à-Pitre
Pointe-à-Pitre, 97159
About this study
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.
Read the 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.
- Conditions
- Hypertension Arterial
- Being tested
- Patient not SAHOS, Patient SAHOS sailed by the ventilation in PPC and not sailed
- Keywords
- sleep apnea, arterial hypertension, cardiovascular risk
- Medical subject headings
- Hypertension, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient not SAHOSOther
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 sailedOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Patient SAHOS sailed by the ventilation in PPC and not sailed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the of the enrollment period, an average of 3 years", etc.).
Secondary outcomes (1)
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
Measured: "through study completion, an average of 8 years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start9 Sep 2008
- Primary completion19 Nov 2014
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension ArterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel BILLY BRISSAC, Dorctor cardiovascular, Principal investigator, Hospital University Center of Pointe-à-Pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373357
- Sponsor's protocol ID
- RBM-PAP- 2007/19
- Acronym
- HTA-SAHOS
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)
- ClinicalTrials.gov ID
- NCT03373357
- Acronym / sponsor ID
- HTA-SAHOS / RBM-PAP- 2007/19
- Conditions
- Hypertension Arterial
- Keywords
- sleep apnea, arterial hypertension, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 9 Sep 2008 (actual)
- Primary completion
- 19 Nov 2014 (actual)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All the patients will have sampling blood specific to the protocol: * Insulinémie * US CRP(TEACHERS' CENTRE) * Implementation of a sérothèque
| Arm | Type | Receives |
|---|---|---|
| Patient not SAHOS | Other | Other: Patient not SAHOSThe 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. |
| Patient SAHOS sailed by the ventilation in PPC and not sailed | Other | Other: Patient SAHOS sailed by the ventilation in PPC and not sailedThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient not SAHOSPhone 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 | Other | Patient not SAHOS |
| Patient SAHOS sailed by the ventilation in PPC and not sailedQuestionnaire 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 | Other | Patient SAHOS sailed by the ventilation in PPC and not sailed |
Primary outcome
the frequency of hypertension
Time frame: 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.
1 secondary outcome
The cardio-metabolic factors
Time frame: "through study completion, an average of 8 years"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel BILLY BRISSAC, Dorctor cardiovascular principal investigator
Hospital University Center of Pointe-à-Pitre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient not SAHOS and Patient SAHOS sailed by the ventilation in PPC and not sailed in people with Hypertension Arterial, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of hypertension (time frame: At the of the enrollment period, an average of 3 years", etc.).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.