Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome

NCT ID: NCT00764218

Last Updated: 2008-10-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Syndrome Hypertension

Keywords

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Obstructive sleep apnea syndrome Hypertension Cardiovascular phenotype

Study Design

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Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SAS+HTA+

Obstructive sleep apnea syndrome and hypertension

Group Type EXPERIMENTAL

Positive airway pressure treatment

Intervention Type DEVICE

Positive airway pressure treatment as long as necessary

SAS+HTA-

non hypertensive patients with obstructive sleep apnea syndrome

Group Type EXPERIMENTAL

Positive airway pressure treatment

Intervention Type DEVICE

Positive airway pressure treatment as long as necessary

SAS-HTA+

hypertensive patients without obstructive sleep apnea syndrome

Group Type EXPERIMENTAL

No positive airway pressure treatment

Intervention Type OTHER

No treatment

SAS-HTA-

non hypertensive patients without obstructive sleep apnea syndrome

Group Type EXPERIMENTAL

No positive airway pressure treatment

Intervention Type OTHER

No treatment

Interventions

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Positive airway pressure treatment

Positive airway pressure treatment as long as necessary

Intervention Type DEVICE

No positive airway pressure treatment

No treatment

Intervention Type OTHER

Other Intervention Names

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CPAP treatment No CPAP treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Philippe JB BAGUET, PhD

Role: CONTACT

Phone: 00330476764226

Email: [email protected]

Jean-Louis JP PEPIN, PhD

Role: CONTACT

Phone: 00330476768473

Email: [email protected]

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.

Reference Type BACKGROUND
PMID: 9367465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9383171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1328361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7846459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1730456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8912770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10805822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10770144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10673727 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20562120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20057899 (View on PubMed)

Other Identifiers

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DGS2001/0398

Identifier Type: -

Identifier Source: org_study_id