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

Primary Purpose

Obstructive Sleep Apnea Syndrome, Hypertension

Status
Unknown status
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Positive airway pressure treatment
No positive airway pressure treatment
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive sleep apnea syndrome, Hypertension, Cardiovascular phenotype

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cardiology and hypertension serviceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

SAS+HTA+

SAS+HTA-

SAS-HTA+

SAS-HTA-

Arm Description

Obstructive sleep apnea syndrome and hypertension

non hypertensive patients with obstructive sleep apnea syndrome

hypertensive patients without obstructive sleep apnea syndrome

non hypertensive patients without obstructive sleep apnea syndrome

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 30, 2008
Last Updated
September 30, 2008
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00764218
Brief Title
Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome
Acronym
SAS-HTA
Official Title
Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome : Role of Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2003 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Hypertension
Keywords
Obstructive sleep apnea syndrome, Hypertension, Cardiovascular phenotype

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAS+HTA+
Arm Type
Experimental
Arm Description
Obstructive sleep apnea syndrome and hypertension
Arm Title
SAS+HTA-
Arm Type
Experimental
Arm Description
non hypertensive patients with obstructive sleep apnea syndrome
Arm Title
SAS-HTA+
Arm Type
Experimental
Arm Description
hypertensive patients without obstructive sleep apnea syndrome
Arm Title
SAS-HTA-
Arm Type
Experimental
Arm Description
non hypertensive patients without obstructive sleep apnea syndrome
Intervention Type
Device
Intervention Name(s)
Positive airway pressure treatment
Other Intervention Name(s)
CPAP treatment
Intervention Description
Positive airway pressure treatment as long as necessary
Intervention Type
Other
Intervention Name(s)
No positive airway pressure treatment
Other Intervention Name(s)
No CPAP treatment
Intervention Description
No treatment
Primary Outcome Measure Information:
Title
cardiovascular phenotype study in patients with non treated obstructive sleep apnea syndrome
Time Frame
6 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe JB BAGUET, PhD
Phone
00330476764226
Ext
64226
Email
JBaguet@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Louis JP PEPIN, PhD
Phone
00330476768473
Ext
68473
Email
JPepin@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe JB BAGUET, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology and hypertension service
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe JB BAGUET, PhD
Phone
0033476764226
Ext
64226
Email
JBaguet@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jean-Louis JP PEPIN, PhD
Phone
0033476768473
Ext
68473
Email
JPepin@chu-grenoble.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
9367465
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
1328361
Citation
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Results Reference
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PubMed Identifier
7846459
Citation
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PubMed Identifier
1730456
Citation
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.
Results Reference
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PubMed Identifier
8912770
Citation
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.
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PubMed Identifier
10805822
Citation
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PubMed Identifier
10770144
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
derived

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Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome

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