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Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing. (SAOS)

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Aging, Telomere length

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria

Patient:

  • Men aged 20 to 65 years
  • Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
  • With an AHI > 5 / h

Healthy volunteers:

  • Men aged 20 to 65 years
  • With an AHI ≤ 5 / h

Exclusion Criteria

All subjects:

  • Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
  • Known cardiovascular disease associated (heart failure, rhythm disorder ...)
  • Known respiratory diseases
  • Known neoplastic pathology, known chronic inflammatory disease
  • Psychiatric pathology treated
  • Medication
  • Not affiliated to the French social health care system
  • Major protected person
  • Private person of liberty
  • People in emergency situation
  • Patient refusing to participate in the study

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Severe OSA

Moderate OSA

Healthy volunteers

Arm Description

Patients with severe OSA (AHI > 30)

Patients with moderate OSA (5 < AHI ≤ 30)

Healthy volunteers (AHI ≤ 5)

Outcomes

Primary Outcome Measures

Telomere length of circulating leukocytes

Secondary Outcome Measures

Carotid-femoral pulse wave velocity
Bone density
Correlation between biological parameters and neuropsychological assessment
Markers of oxidative stress: Malondialdehyde, heme oxygenase-1
Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1
Markers of growth hormone axis (GH, IGF-1, IGFBP)

Full Information

First Posted
July 31, 2016
Last Updated
August 18, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02876653
Brief Title
Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
Acronym
SAOS
Official Title
Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Aging, Telomere length

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Severe OSA
Arm Type
Other
Arm Description
Patients with severe OSA (AHI > 30)
Arm Title
Moderate OSA
Arm Type
Other
Arm Description
Patients with moderate OSA (5 < AHI ≤ 30)
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers (AHI ≤ 5)
Intervention Type
Other
Intervention Name(s)
Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
Intervention Description
Blood collection, Bone densitometry and Functional respiratory explorations are a specific interventions of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " healthy volunteers "
Primary Outcome Measure Information:
Title
Telomere length of circulating leukocytes
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Carotid-femoral pulse wave velocity
Time Frame
4 weeks
Title
Bone density
Time Frame
4 weeks
Title
Correlation between biological parameters and neuropsychological assessment
Time Frame
4 weeks
Title
Markers of oxidative stress: Malondialdehyde, heme oxygenase-1
Time Frame
4 weeks
Title
Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1
Time Frame
4 weeks
Title
Markers of growth hormone axis (GH, IGF-1, IGFBP)
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Patient: Men aged 20 to 65 years Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil With an AHI > 5 / h Healthy volunteers: Men aged 20 to 65 years With an AHI ≤ 5 / h Exclusion Criteria All subjects: Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated, Known cardiovascular disease associated (heart failure, rhythm disorder ...) Known respiratory diseases Known neoplastic pathology, known chronic inflammatory disease Psychiatric pathology treated Medication Not affiliated to the French social health care system Major protected person Private person of liberty People in emergency situation Patient refusing to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Boyer, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

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Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

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