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

September 30, 2008 updated by: University Hospital, Grenoble

Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome : Role of Hypertension

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38000
        • Recruiting
        • Cardiology and hypertension service
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAS+HTA+
Obstructive sleep apnea syndrome and hypertension
Device: Positive airway pressure treatment
Positive airway pressure treatment as long as necessary
Other Names:
  • 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 Names:
  • CPAP treatment
Experimental: SAS-HTA+
hypertensive patients without obstructive sleep apnea syndrome
Other: No positive airway pressure treatment
No treatment
Other Names:
  • No CPAP treatment
Experimental: SAS-HTA-
non hypertensive patients without obstructive sleep apnea syndrome
Other: No positive airway pressure treatment
No treatment
Other Names:
  • No CPAP treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiovascular phenotype study in patients with non treated obstructive sleep apnea syndrome
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Philippe JB BAGUET, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Anticipated)

December 1, 2003

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2008

Last Update Submitted That Met QC Criteria

September 30, 2008

Last Verified

January 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS2001/0398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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