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OpenTrials
Completed

NCT Number: NCT02876653

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

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)

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Other

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 outcomes

  1. Telomere length of circulating leukocytes

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: SAOS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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