NCT00764218

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2001

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 1, 2008

Status Verified

January 1, 2001

Enrollment Period

2.8 years

First QC Date

September 30, 2008

Last Update Submit

September 30, 2008

Conditions

Obstructive Sleep Apnea SyndromeHypertension

Keywords

Obstructive sleep apnea syndromeHypertensionCardiovascular phenotype

Outcome Measures

Primary Outcomes (1)

  • cardiovascular phenotype study in patients with non treated obstructive sleep apnea syndrome

    6 years

Secondary Outcomes (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.

    6 years

Study Arms (4)

SAS+HTA+

EXPERIMENTAL

Obstructive sleep apnea syndrome and hypertension

Device: Positive airway pressure treatment

SAS+HTA-

EXPERIMENTAL

non hypertensive patients with obstructive sleep apnea syndrome

Device: Positive airway pressure treatment

SAS-HTA+

EXPERIMENTAL

hypertensive patients without obstructive sleep apnea syndrome

Other: No positive airway pressure treatment

SAS-HTA-

EXPERIMENTAL

non hypertensive patients without obstructive sleep apnea syndrome

Other: No positive airway pressure treatment

Interventions

Positive airway pressure treatmentDEVICE

Positive airway pressure treatment as long as necessary

Also known as: CPAP treatment
SAS+HTA+SAS+HTA-
No positive airway pressure treatmentOTHER

No treatment

Also known as: No CPAP treatment
SAS-HTA+SAS-HTA-

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with or without obstructive sleep apnea syndrome (AHI \> 15)
  • patients with or without hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology and hypertension service

Grenoble, Isère, 38000, France

RECRUITING

Related Publications (11)

  • 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.

    PMID: 9367465BACKGROUND

  • 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.

    PMID: 9383171BACKGROUND

  • 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.

    PMID: 1328361BACKGROUND

  • 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.

    PMID: 7846459BACKGROUND

  • 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.

    PMID: 1730456BACKGROUND

  • 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.

    PMID: 8912770BACKGROUND

  • 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.

    PMID: 10805822BACKGROUND

  • 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.

    PMID: 10770144BACKGROUND

  • 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.

    PMID: 10673727BACKGROUND

  • 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.

    PMID: 20562120DERIVED

  • 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.

    PMID: 20057899DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Jean-Philippe JB BAGUET, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Philippe JB BAGUET, PhD

CONTACT

00330476764226JBaguet@chu-grenoble.fr

Jean-Louis JP PEPIN, PhD

CONTACT

00330476768473JPepin@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
early phase 1
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

March 1, 2001

Primary Completion

December 1, 2003

Study Completion

December 1, 2008

Last Updated

October 1, 2008

Record last verified: 2001-01

Locations

FR(1)