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Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome

Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome : Role of Hypertension

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00764218
Acronym
SAS-HTA
Enrollment
300
Registered
2008-10-01
Start date
2001-03-31
Completion date
2008-12-31
Last updated
2008-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obstructive Sleep Apnea Syndrome

Keywords

Obstructive sleep apnea syndrome, Hypertension, Cardiovascular phenotype

Brief summary

Patients with obstructive sleep apnea syndrome have permanent variations of their hemodynamic parameters during the night : heart rate, arterial blood pressure, cardiac output. This is due to the repetition of respiratory events (obstructive apnea and hypopnea) leading to frequent micro-arousals. These disorders have several consequences : hypertension, NO-dependent vasodilatation impairment, baroreceptor reflex impairment, insulin resistance and other cardiovascular impairments.

Detailed description

Objective of the study is to characterize the cardiovascular phenotype of patients with obstructive sleep apnea syndrome, relative to the presence of hypertension or not. Hypertension should not have been previously treated. 2 groups of apneic patients (SAS+HTA+ and SAS+HTA-) will be compared together, referred to group of non apneic but hypertensive patients (SAS-HTA+) and non apneic / non hypertensive patients (SAS-HTA-). Apneic and hypertensive patients may have a sympathetic nervous system activation and a much more important vascular and baroreceptor reflex impairment, than non apneic but hypertensive patients. During the study, a second visit as control will be done for apneic patients only, 3 to 6 months after SAS treatment setting.

Interventions

DEVICEPositive airway pressure treatment

Positive airway pressure treatment as long as necessary

OTHERNo positive airway pressure treatment

No treatment

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* patients with or without obstructive sleep apnea syndrome (AHI \> 15) * patients with or without hypertension

Exclusion criteria

* known or expected secondary hypertension * pathologies with consequences on arterial blood pressure regulation: Parkinson's disease, patients with renal or cardiac graft, severe heart failure * drugs with consequences on arterial blood pressure regulation : vasoconstrictors, vasodilatators, béta-agonists, antagonists, nitrites, theophylline, dipyridamol, sildenafil, immunosuppressors, IMAO, neuroleptics, tricyclic antidepressants, corticoids or long-term oral (\>10 days) non steroidal anti-inflammatory drugs, oestroprogestative treatments * atrial fibrillation, frequent extrasystoles (\> or = to 10/minute) * bedridden patients * night shift workers * surgical or carotid stenting history * subjects unwilling or unable to provide written, signed and dated informed consent * patient previously treated for obstructive sleep apnea syndrome (positive airway pressure, forward mandible prosthesis, maxillofacial surgery

Design outcomes

Primary

MeasureTime frame
cardiovascular phenotype study in patients with non treated obstructive sleep apnea syndrome6 years

Secondary

MeasureTime frame
characterization of arterial blood pressure, sympathetic activity, functional and morphological cardiovascular modifications. Effect of a treatment of obstructive sleep apnea syndrome on those different parameters.6 years

Countries

France

Contacts

Primary ContactJean-Philippe JB BAGUET, PhD
JBaguet@chu-grenoble.fr00330476764226
Backup ContactJean-Louis JP PEPIN, PhD
JPepin@chu-grenoble.fr00330476768473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026