Obstructive Sleep ApneaSAOSNCT02876653
Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
A study testing Polysomnography , blood collection, bone densitometry and Functional respiratory explorations in people with Obstructive Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
- Keywords
- Obstructive sleep apnea, Aging, Telomere length
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography , blood collection, bone densitometry and Functional respiratory explorationsOther
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 "
| Study group | Role | What they receive |
|---|---|---|
| Severe OSA | Other | Patients with severe OSA (AHI > 30) Receives: Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations |
| Moderate OSA | Other | Patients with moderate OSA (5 < AHI ≤ 30) Receives: Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations |
| Healthy volunteers | Other | Healthy volunteers (AHI ≤ 5) Receives: Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length of circulating leukocytes
Measured: 4 weeks
Secondary outcomes (6)
Carotid-femoral pulse wave velocity
Measured: 4 weeks
Bone density
Measured: 4 weeks
Correlation between biological parameters and neuropsychological assessment
Measured: 4 weeks
Markers of oxidative stress: Malondialdehyde, heme oxygenase-1
Measured: 4 weeks
Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1
Measured: 4 weeks
Markers of growth hormone axis (GH, IGF-1, IGFBP)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startMar 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Boyer, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876653
- Sponsor's protocol ID
- P091110
- Acronym
- SAOS
- Status last verified
- Jul 2016
- First submitted
- 31 Jul 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
- ClinicalTrials.gov ID
- NCT02876653
- Acronym / sponsor ID
- SAOS / P091110
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Aging, Telomere length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe OSA | Other | Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorationsPatients with severe OSA (AHI > 30) |
| Moderate OSA | Other | Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorationsPatients with moderate OSA (5 < AHI ≤ 30) |
| Healthy volunteers | Other | Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorationsHealthy volunteers (AHI ≤ 5) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men aged 20 to 65 years
- Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
- With an AHI > 5 / h
- Men aged 20 to 65 years
- With an AHI ≤ 5 / h
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysomnography , blood collection, bone densitometry and Functional respiratory explorationsBlood 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, Moderate OSA, Severe OSA |
Primary outcome
Telomere length of circulating leukocytes
Time frame: 4 weeks
6 secondary outcomes
Carotid-femoral pulse wave velocity
Time frame: 4 weeks
Bone density
Time frame: 4 weeks
Correlation between biological parameters and neuropsychological assessment
Time frame: 4 weeks
Markers of oxidative stress: Malondialdehyde, heme oxygenase-1
Time frame: 4 weeks
Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1
Time frame: 4 weeks
Markers of growth hormone axis (GH, IGF-1, IGFBP)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Boyer, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography , blood collection, bone densitometry and Functional respiratory explorations in people with Obstructive Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length of circulating leukocytes (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.