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Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome (SAS-HTA)

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ClinicalTrials.gov Identifier: NCT00764218
Recruitment Status : Unknown
Verified January 2001 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : October 1, 2008
Last Update Posted : October 1, 2008
Sponsor:
Information provided by:
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Hypertension Device: Positive airway pressure treatment Other: No positive airway pressure treatment Early Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome : Role of Hypertension
Study Start Date : March 2001
Estimated Primary Completion Date : December 2003
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SAS+HTA+
Obstructive sleep apnea syndrome and hypertension
Device: Positive airway pressure treatment
Positive airway pressure treatment as long as necessary
Other Name: CPAP treatment
Experimental: SAS+HTA-
non hypertensive patients with obstructive sleep apnea syndrome
Device: Positive airway pressure treatment
Positive airway pressure treatment as long as necessary
Other Name: CPAP treatment
Experimental: SAS-HTA+
hypertensive patients without obstructive sleep apnea syndrome
Other: No positive airway pressure treatment
No treatment
Other Name: No CPAP treatment
Experimental: SAS-HTA-
non hypertensive patients without obstructive sleep apnea syndrome
Other: No positive airway pressure treatment
No treatment
Other Name: No CPAP treatment



Primary Outcome Measures :
  1. cardiovascular phenotype study in patients with non treated obstructive sleep apnea syndrome [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 6 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764218


Contacts
Contact: Jean-Philippe JB BAGUET, PhD 00330476764226 ext 64226 JBaguet@chu-grenoble.fr
Contact: Jean-Louis JP PEPIN, PhD 00330476768473 ext 68473 JPepin@chu-grenoble.fr

Locations
France
Cardiology and hypertension service Recruiting
Grenoble, Isère, France, 38000
Contact: Jean-Philippe JB BAGUET, PhD    0033476764226 ext 64226    JBaguet@chu-grenoble.fr   
Contact: Jean-Louis JP PEPIN, PhD    0033476768473 ext 68473    JPepin@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Philippe JB BAGUET, PhD University Hospital, Grenoble

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BAGUET Jean-Philippe, PhD, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT00764218     History of Changes
Other Study ID Numbers: DGS2001/0398
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: January 2001

Keywords provided by University Hospital, Grenoble:
Obstructive sleep apnea syndrome
Hypertension
Cardiovascular phenotype

Additional relevant MeSH terms:
Syndrome
Hypertension
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases