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

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ClinicalTrials.gov Identifier: NCT02876653
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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)

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
Study Start Date : March 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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 "

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 "

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 "




Primary Outcome Measures :
  1. Telomere length of circulating leukocytes [ Time Frame: 4 weeks ]

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


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876653


Locations
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France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Laurent Boyer, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02876653     History of Changes
Other Study ID Numbers: P091110
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: July 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obstructive sleep apnea
Aging
Telomere length

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases