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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00764218
First received: September 30, 2008
Last updated: NA
Last verified: January 2001
History: No changes posted
  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

Study Type: Interventional
Study Design: Intervention Model: Factorial Assignment
Masking: 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:

Additional 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
Study First Received: September 30, 2008
Last Updated: September 30, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Obstructive sleep apnea syndrome
Hypertension
Cardiovascular phenotype

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Sleep Disorders
Hypertension
Syndrome
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Dyssomnias
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014