CClinicalTrials.gg
CompletedNCT02876653SAOSUpdated Aug 24, 2016

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

An interventional study of Polysomnography , blood collection, bone densitometry and Functional respiratory explorations in Obstructive Sleep Apnea, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to male participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-24.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
Male
01

Study 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)

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Obstructive sleep apnea
  • Aging
  • Telomere length
03

In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 53 is close to the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Other
    Severe OSA

    Patients with severe OSA (AHI \> 30)

    Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

  • Other
    Moderate OSA

    Patients with moderate OSA (5 \< AHI ≤ 30)

    Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

  • Other
    Healthy volunteers

    Healthy volunteers (AHI ≤ 5)

    Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Interventions

  • OtherPolysomnography , 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 "

06

What researchers measure

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

07

Study locations

1 site
  • Henri Mondor Hospital
    Creteil, 94010, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02876653
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Aug 24, 2016
Start date
Mar 2011
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Aug 24, 2016

Study contacts

Laurent Boyer, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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