Obstructive Sleep ApneaMIR-OSANCT06189755
MicroRNAs as Biomarkers for Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by University of Pennsylvania at 3 sites in 2 countries.
Trial summary
Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients. This project will study microRNAs in order to develop and validate blood biomarkers that are specific to OSA, useful for identification of cases with OSA, reflective of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Apr 2024to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: Participants who had a clinical sleep study who meet inclusion criteria for age and AHI and none of the exclusion criteria will be identified using the sleep center databases and electronic medical records. The investigators will also recruit participants from the community- these participants will undergo home sleep study with EEG. The investigators will make a conscious effort to recruit from all ethnic and social economic backgrounds.
Who may be able to join
- age 18-75 years
- moderate-severe OSA (defined as AHI ≥15 events/hour)
- willing to accept PAP therapy
- age 18-75 years
- no OSA (defined as AHI <5 events/hour)
Who cannot join
- current use of PAP or other OSA treatments
- home oxygen therapy
- recent changes (within 3 months) to BP medications among those who are on these medications
- presence of Cheyne-Stokes Respiration (CSR) in sleep study
- predominantly central sleep apnea (AHI≥15 events/hour, with >50% central events)
- pregnancy
Show all 16Show fewer
- clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
- organ transplantation
- self-reported sleep duration less than 5 hours per night on weeknights (work nights)
- current night shift work
- home oxygen therapy
- pregnancy
- clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
- organ transplantation
- self-reported sleep duration less than 5 hours per night on weeknights (work nights)
- current night shift work
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600
Columbus, Ohio, 43221
Ulysses J Magalang, MD, 614-292-4307, ulysses.magalang@osumc.edu
Ulysses J Magalang, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Colleen M Walsh, MS, 215-614-0047, walshco@pennmedicine.upenn.edu
Allan I Pack, MBChB, PhD, 215-746-4806, pack@pennmedicine.upenn.edu
Iceland1 site, 1 recruiting
- Recruiting
University of Iceland
Reykjavik
Thorarinn Gislason, MD, thorarig@landspitali.is
Thorarinn Gislason, MD
About this study
Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients. This project will study microRNAs in order to develop and validate blood biomarkers that are specific to OSA, useful for identification of cases with OSA, reflective of efficacy of therapy, and able to predict blood pressure response to treatment of OSA.
Read the detailed description
While obstructive sleep apnea (OSA) is common, there are limited biomarkers for identification and management of the condition. Specific use cases for an OSA biomarker include: (i) improving case identification, (ii) monitoring efficacy of therapy, and (iii) providing prognostic value with respect to who will get particular consequences or how individuals respond to continuous positive airway pressure (CPAP) treatment. While different approaches can be used to define biomarkers, this project will focus on microRNAs, which have very recently been shown to be promising biomarkers in OSA. MicroRNAs are small non-coding RNAs that alter the translation of protein coding RNA. Their expression is dynamic and altered by many challenges, such as hypoxia. Expression of all microRNAs in blood can be assessed by sequencing all short RNAs. Prior studies, albeit with small sample sizes, suggest differences in microRNA expression between OSA cases and controls and that differences in microRNA expression can identify individuals with OSA who will show larger blood pressure responses to CPAP treatment. Using complementary sequencing approaches and clinically-feasible quantitative PCR (qPCR), the investigators propose to validate and extend these initial observations. First, the investigators will seek biomarkers that are specific to OSA by evaluating differences in microRNA profiles between cases with OSA and controls without OSA matched for age, sex, and body mass index and without other underlying conditions that could independently affect microRNA expression. While identifying microRNAs specific to OSA is important, it is also useful to determine microRNAs useful for improving OSA case identification beyond known clinical risk factors. Thus, this project will enroll a larger case-control sample with minimal exclusion criteria in which to assess the predictive value of differences in microRNA expression. To understand the utility of microRNAs as treatment-related biomarkers, cases with OSA will be studied before and after 6 months of CPAP. The investigators anticipate that some microRNAs specific to OSA will normalize with CPAP treatment, thus providing an objective measure of effectiveness. In all OSA cases, the investigators will assess 24-hour ambulatory blood pressure to validate and extend recent reports of a microRNA signature that predicts blood pressure response to CPAP. The investigators will conduct robust validation for all biomarkers.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Positive Airway Pressure
- Keywords
- Sleep Apnea, Biomarkers, Blood pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway PressureDevice
Case participants will use Positive Airway Pressure (PAP) treatment as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Moderate-severe OSA (defined as AHI ≥15 events/hour) Receives: Device: Positive Airway Pressure | |
| Controls | No OSA (defined as AHI <5 events/hour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA
Changes in circulating microRNA profile
Measured: Once at baseline, and after 6 months of PAP treatment, if applicable
Secondary outcomes (1)
24-hour mean blood pressure (24hMBP)
Ambulatory blood pressure monitoring of systolic and diastolic blood pressure
Measured: Measured for 24-hours at baseline, and repeated after 6 months of PAP treatment, if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
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 University of PennsylvaniaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Allan I Pack, MBChB, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189755
- Sponsor's protocol ID
- 854567
- Other IDs
- 1P01HL160471-01A1
- Acronym
- MIR-OSA
- Status last verified
- Jul 2026
- First submitted
- 6 Dec 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs as Biomarkers for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06189755
- Acronym / sponsor ID
- MIR-OSA / 854567
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep Apnea, Biomarkers, Blood pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 5 Jan 2024 (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.
Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients. This project will study microRNAs in order to develop and validate blood biomarkers that are specific to OSA, useful for identification of cases with OSA, reflective of efficacy of therapy, and able to predict blood pressure response to treatment of OSA.
Detailed description
While obstructive sleep apnea (OSA) is common, there are limited biomarkers for identification and management of the condition. Specific use cases for an OSA biomarker include: (i) improving case identification, (ii) monitoring efficacy of therapy, and (iii) providing prognostic value with respect to who will get particular consequences or how individuals respond to continuous positive airway pressure (CPAP) treatment. While different approaches can be used to define biomarkers, this project will focus on microRNAs, which have very recently been shown to be promising biomarkers in OSA. MicroRNAs are small non-coding RNAs that alter the translation of protein coding RNA. Their expression is dynamic and altered by many challenges, such as hypoxia. Expression of all microRNAs in blood can be assessed by sequencing all short RNAs. Prior studies, albeit with small sample sizes, suggest differences in microRNA expression between OSA cases and controls and that differences in microRNA expression can identify individuals with OSA who will show larger blood pressure responses to CPAP treatment. Using complementary sequencing approaches and clinically-feasible quantitative PCR (qPCR), the investigators propose to validate and extend these initial observations. First, the investigators will seek biomarkers that are specific to OSA by evaluating differences in microRNA profiles between cases with OSA and controls without OSA matched for age, sex, and body mass index and without other underlying conditions that could independently affect microRNA expression. While identifying microRNAs specific to OSA is important, it is also useful to determine microRNAs useful for improving OSA case identification beyond known clinical risk factors. Thus, this project will enroll a larger case-control sample with minimal exclusion criteria in which to assess the predictive value of differences in microRNA expression. To understand the utility of microRNAs as treatment-related biomarkers, cases with OSA will be studied before and after 6 months of CPAP. The investigators anticipate that some microRNAs specific to OSA will normalize with CPAP treatment, thus providing an objective measure of effectiveness. In all OSA cases, the investigators will assess 24-hour ambulatory blood pressure to validate and extend recent reports of a microRNA signature that predicts blood pressure response to CPAP. The investigators will conduct robust validation for all biomarkers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Device: Positive Airway PressureModerate-severe OSA (defined as AHI ≥15 events/hour) |
| Controls | – | –No OSA (defined as AHI <5 events/hour) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants who had a clinical sleep study who meet inclusion criteria for age and AHI and none of the exclusion criteria will be identified using the sleep center databases and electronic medical records. The investigators will also recruit participants from the community- these participants will undergo home sleep study with EEG. The investigators will make a conscious effort to recruit from all ethnic and social economic backgrounds.
Key inclusion criteria (5 listed)
- age 18-75 years
- moderate-severe OSA (defined as AHI ≥15 events/hour)
- willing to accept PAP therapy
- age 18-75 years
- no OSA (defined as AHI <5 events/hour)
Key exclusion criteria (16 listed)
- current use of PAP or other OSA treatments
- home oxygen therapy
- recent changes (within 3 months) to BP medications among those who are on these medications
- presence of Cheyne-Stokes Respiration (CSR) in sleep study
- predominantly central sleep apnea (AHI≥15 events/hour, with >50% central events)
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 |
|---|---|---|
| Positive Airway PressureCase participants will use Positive Airway Pressure (PAP) treatment as part of routine clinical care. | Device | Cases |
Primary outcome
microRNA
Time frame: Once at baseline, and after 6 months of PAP treatment, if applicable
Changes in circulating microRNA profile
1 secondary outcome
24-hour mean blood pressure (24hMBP)
Time frame: Measured for 24-hours at baseline, and repeated after 6 months of PAP treatment, if applicable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Allan I Pack, MBChB, PhD principal investigator
University of Pennsylvania
3 sites in 2 countries: 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 University of Pennsylvania at 3 sites in 2 countries.
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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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, Iceland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colleen M Walsh, MS (215-614-0047, walshco@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA (time frame: Once at baseline, and after 6 months of PAP treatment, if applicable). 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 3 Aug 2026.