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

August 18, 2016 updated by: Assistance Publique - Hôpitaux de Paris
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Severe OSA
Patients with severe OSA (AHI > 30)
Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
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 "
Other: Moderate OSA
Patients with moderate OSA (5 < AHI ≤ 30)
Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
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 "
Other: Healthy volunteers
Healthy volunteers (AHI ≤ 5)
Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
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 "

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Telomere length of circulating leukocytes
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Carotid-femoral pulse wave velocity
Time Frame: 4 weeks
4 weeks
Bone density
Time Frame: 4 weeks
4 weeks
Correlation between biological parameters and neuropsychological assessment
Time Frame: 4 weeks
4 weeks
Markers of oxidative stress: Malondialdehyde, heme oxygenase-1
Time Frame: 4 weeks
4 weeks
Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1
Time Frame: 4 weeks
4 weeks
Markers of growth hormone axis (GH, IGF-1, IGFBP)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Laurent Boyer, MD, Assistance Publique - Hôpitaux de Paris

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, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P091110

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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