Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome
NCT ID: NCT00764218
Last Updated: 2008-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
300 participants
INTERVENTIONAL
2001-03-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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SAS+HTA+
Obstructive sleep apnea syndrome and hypertension
Positive airway pressure treatment
Positive airway pressure treatment as long as necessary
SAS+HTA-
non hypertensive patients with obstructive sleep apnea syndrome
Positive airway pressure treatment
Positive airway pressure treatment as long as necessary
SAS-HTA+
hypertensive patients without obstructive sleep apnea syndrome
No positive airway pressure treatment
No treatment
SAS-HTA-
non hypertensive patients without obstructive sleep apnea syndrome
No positive airway pressure treatment
No treatment
Interventions
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Positive airway pressure treatment
Positive airway pressure treatment as long as necessary
No positive airway pressure treatment
No treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with or without hypertension
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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University Hospital Grenoble
Principal Investigators
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Jean-Philippe JB BAGUET, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Cardiology and hypertension service
Grenoble, Isère, France
Countries
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Central Contacts
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Facility Contacts
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Jean-Philippe JB BAGUET, PhD
Role: primary
Jean-Louis JP PEPIN, PhD
Role: backup
References
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Pankow W, Nabe B, Lies A, Becker H, Kohler U, Kohl FV, Lohmann FW. Influence of sleep apnea on 24-hour blood pressure. Chest. 1997 Nov 5;112(5):1253-8. doi: 10.1378/chest.112.5.1253.
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. doi: 10.1097/00004872-199715110-00006.
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. doi: 10.1093/sleep/17.7.614.
Landsberg L. Hyperinsulinemia: possible role in obesity-induced hypertension. Hypertension. 1992 Jan;19(1 Suppl):I61-6. doi: 10.1161/01.hyp.19.1_suppl.i61.
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. doi: 10.1164/ajrccm.154.5.8912770.
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. doi: 10.1056/NEJM200005113421901.
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. doi: 10.1001/jama.283.14.1829.
Baguet JP, Mallion JM, Moreau-Gaudry A, Noirclerc M, Peoc'h M, Siche JP. Relationships between cardiovascular remodelling and the pulse pressure in never treated hypertension. J Hum Hypertens. 2000 Jan;14(1):23-30. doi: 10.1038/sj.jhh.1000933.
Baguet JP, Barone-Rochette G, Levy P, Vautrin E, Pierre H, Ormezzano O, Pepin JL. Left ventricular diastolic dysfunction is linked to severity of obstructive sleep apnoea. Eur Respir J. 2010 Dec;36(6):1323-9. doi: 10.1183/09031936.00165709. Epub 2010 Jun 18.
Baguet JP, Nadra M, Barone-Rochette G, Ormezzano O, Pierre H, Pepin JL. Early cardiovascular abnormalities in newly diagnosed obstructive sleep apnea. Vasc Health Risk Manag. 2009;5:1063-73. doi: 10.2147/vhrm.s8300. Epub 2009 Dec 29.
Other Identifiers
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DGS2001/0398
Identifier Type: -
Identifier Source: org_study_id