Obstructive Sleep ApneaNCT03122483
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
An observational study of Obstructive Sleep Apnea, run by Beckman Coulter, Inc. at 3 sites in United States.
Trial summary
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- blood biomarker
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to 14 Jul 2017
- Phase
- Observational
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic patients with a clinical suspicion of obstructive sleep apnea
Who may be able to join
- Written Informed Consent
- Male
- 18-70 years old
- Presentation with symptoms suggestive of obstructive sleep apnea
- Diagnostic sleep study
- Blood draw
Who cannot join
- Prior (within past year) or current therapy for sleep apnea
- Use of opioid pain medication, steroids or allopurinol (within past 30 days)
- Use of chronic anti-inflammatory drugs (within past 7 days)
- Active cancer under current treatment or monitoring
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
SleepMed
Columbia, South Carolina, 29201
Sleep Center Orange County
Irvine, California, 92604
About this study
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- blood biomarker
- 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.
blood biomarkerDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| OSA | Blood biomarker results in subjects with obstructive sleep apnea. Receives: Diagnostic Test: blood biomarker | |
| Non-OSA | Blood biomarker results in subjects without obstructive sleep apnea Receives: Diagnostic Test: blood biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of OSA in high-risk individuals
Identification of OSA in high-risk individuals
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study startJan 2016
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paula C Southwick, PhD, Study director, Beckman Coulter, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122483
- Sponsor's protocol ID
- SAB-03-15
- Status last verified
- Aug 2017
- First submitted
- 17 Apr 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fleming WE, Ferouz-Colborn A, Samoszuk MK, Azad A, Lu J, Riley JS, Cruz AB, Podolak S, Clark DJ, Bray KR, Southwick PC. Blood biomarkers of endocrine, immune, inflammatory, and metabolic systems in obstructive sleep apnea. Clin Biochem. 2016 Aug;49(12):854-61. doi: 10.1016/j.clinbiochem.2016.05.005. Epub 2016 May 13.
PubMed 27184708
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT03122483
- Acronym / sponsor ID
- SAB-03-15
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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.
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA | – | Diagnostic Test: blood biomarkerBlood biomarker results in subjects with obstructive sleep apnea. |
| Non-OSA | – | Diagnostic Test: blood biomarkerBlood biomarker results in subjects without obstructive sleep apnea |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic patients with a clinical suspicion of obstructive sleep apnea
Key inclusion criteria (6 listed)
- Written Informed Consent
- Male
- 18-70 years old
- Presentation with symptoms suggestive of obstructive sleep apnea
- Diagnostic sleep study
Key exclusion criteria (4 listed)
- Prior (within past year) or current therapy for sleep apnea
- Use of opioid pain medication, steroids or allopurinol (within past 30 days)
- Use of chronic anti-inflammatory drugs (within past 7 days)
- Active cancer under current treatment or monitoring
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 |
|---|---|---|
| blood biomarker | Diagnostic test | Non-OSA, OSA |
Primary outcome
Identification of OSA in high-risk individuals
Time frame: 1 day
Identification of OSA in high-risk individuals
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 18 Aug 2017.
- Background: PubMed 27184708Fleming WE, Ferouz-Colborn A, Samoszuk MK, Azad A, Lu J, Riley JS, Cruz AB, Podolak S, Clark DJ, Bray KR, Southwick PC. Blood biomarkers of endocrine, immune, inflammatory, and metabolic systems in obstructive sleep apnea. Clin Biochem. 2016 Aug;49(12):854-61. doi: 10.1016/j.clinbiochem.2016.05.005. Epub 2016 May 13.
- Individual participant dataSharing planned: No
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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.
Paula C Southwick, PhD study director
Beckman Coulter, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Beckman Coulter, Inc. at 3 sites in United States.
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 6 inclusion and 4 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Identification of OSA in high-risk individuals (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03122483, which also lists 1 linked publication.
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 18 Aug 2017.