Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome - Full Text View

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00764218

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	Phase 0

MedlinePlus related topics: High Blood Pressure Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Open Label, Factorial Assignment
Official Title:	Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome : Role of Hypertension

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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, Isère
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.

Responsible Party:	University Hospital Grenoble ( BAGUET Jean-Philippe, PhD )
Study ID Numbers:	DGS2001/0398
Study First Received:	September 30, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00764218
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

Obstructive sleep apnea syndrome
Hypertension
Cardiovascular phenotype

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive

Vascular Diseases
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009