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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2001 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764218
First Posted: October 1, 2008
Last Update Posted: October 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Grenoble
  Purpose
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 Intervention Phase
Obstructive Sleep Apnea Syndrome Hypertension Device: Positive airway pressure treatment Other: No positive airway pressure treatment Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: March 2001
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
Pankow W, Nabe B, Lies A, Becker H, Köhler U, Kohl FV, Lohmann FW. Influence of sleep apnea on 24-hour blood pressure. Chest. 1997 Nov 5;112(5):1253-8.
Portaluppi F, Provini F, Cortelli P, Plazzi G, Bertozzi N, Manfredini R, Fersini C, Lugaresi E. Undiagnosed sleep-disordered breathing among male nondippers with essential hypertension. J Hypertens. 1997 Nov;15(11):1227-33.
Calver A, Collier J, Moncada S, Vallance P. Effect of local intra-arterial NG-monomethyl-L-arginine in patients with hypertension: the nitric oxide dilator mechanism appears abnormal. J Hypertens. 1992 Sep;10(9):1025-31.
Strohl KP, Novak RD, Singer W, Cahan C, Boehm KD, Denko CW, Hoffstem VS. Insulin levels, blood pressure and sleep apnea. Sleep. 1994 Oct;17(7):614-8.
Landsberg L. Hyperinsulinemia: possible role in obesity-induced hypertension. Hypertension. 1992 Jan;19(1 Suppl):I61-6. Review.
Carlson JT, Hedner JA, Sellgren J, Elam M, Wallin BG. Depressed baroreflex sensitivity in patients with obstructive sleep apnea. Am J Respir Crit Care Med. 1996 Nov;154(5):1490-6.
Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84.
Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. Erratum in: JAMA 2002 Oct 23-30;288(16):1985.
Baguet JP, Mallion JM, Moreau-Gaudry A, Noirclerc M, Péoc'h M, Siché JP. Relationships between cardiovascular remodelling and the pulse pressure in never treated hypertension. J Hum Hypertens. 2000 Jan;14(1):23-30.

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 Submitted: September 30, 2008
First Posted: October 1, 2008
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


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