Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index

An observational study of Obstructive Sleep Apnea, run by Milton S. Hershey Medical Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea
How many people: 196 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2017to Dec 2027
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with suspected OS who are being seen at the Sleep Research and Treatment Center.

Who may be able to join

Mild to moderate OSA (5≤ AHI <30)
BMI ≤ 45
Age ≥ 18
Men \& Women

Who cannot join

AHI ≥ 30
BMI >45
Current use of steroids or anti-inflammatory medication
Diagnosis of insulin dependent diabetes
Diagnosis of autoimmune disorder
Shiftwork
Current use of CPAP

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Conditions: Obstructive Sleep Apnea
Medical subject headings: Sleep Apnea, Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

Presence of the metabolic syndrome
At least 3 of the following 5 risk factors must be met in order to have the metabolic syndrome:
1. Elevated waist measurement (≥102 cm for men or ≥89 cm for women)
2. Elevated triglycerides (≥150 mg/dL or use of medication)
3. Low HDL cholesterol (<50 mg/dL for women or <40 mg/dL for men or use of medication)
4. Elevated blood pressure (≥130 mmHg systolic or ≥ 85 mmHg diastolic or use of medication)
5. Elevated fasting blood sugar (≥100 mg/dL or use of medication)
Source: https://www.nhlbi.nih.gov/health/health-topics/topics/ms
Measured: baseline
Obstructive Sleep Apnea
AHI from one night polysomnography
Measured: baseline
Markers of systemic inflammation
CRP, IL-6, TNFa
Measured: baseline

Secondary outcomes (2)

Heart rate variability
from polysomnography
Measured: baseline
Subjective measure of sleepiness
Epworth Sleepiness Scale
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 2017Dec 2027

First posted23 Feb 2017
Study start1 Mar 2017
Primary completionDec 2027 (estimated)
Study completionDec 2027 (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 Milton S. Hershey Medical CenterThe 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 only
Time perspective: Cross-sectional
Enrolment: 196 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03062748
Sponsor's protocol ID: 5218
Status last verified: Apr 2026
First submitted: 16 Feb 2017
Last updated: 23 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index
ClinicalTrials.gov ID: NCT03062748
Acronym / sponsor ID: 5218
Conditions: Obstructive Sleep Apnea
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 196 participants (estimated)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Study start: 1 Mar 2017 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 23 Feb 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.

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with suspected OS who are being seen at the Sleep Research and Treatment Center.

Key inclusion criteria (4 listed)

Mild to moderate OSA (5≤ AHI <30)
BMI ≤ 45
Age ≥ 18
Men \& Women

Key exclusion criteria (7 listed)

AHI ≥ 30
BMI >45
Current use of steroids or anti-inflammatory medication
Diagnosis of insulin dependent diabetes
Diagnosis of autoimmune disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Presence of the metabolic syndrome
Time frame: baseline
At least 3 of the following 5 risk factors must be met in order to have the metabolic syndrome: 1. Elevated waist measurement (≥102 cm for men or ≥89 cm for women) 2. Elevated triglycerides (≥150 mg/dL or use of medication) 3. Low HDL cholesterol (<50 mg/dL for women or <40 mg/dL for men or use of medication) 4. Elevated blood pressure (≥130 mmHg systolic or ≥ 85 mmHg diastolic or use of medication) 5. Elevated fasting blood sugar (≥100 mg/dL or use of medication) Source: https://www.nhlbi.nih.gov/health/health-topics/topics/ms
Obstructive Sleep Apnea
Time frame: baseline
AHI from one night polysomnography
Markers of systemic inflammation
Time frame: baseline
CRP, IL-6, TNFa

2 secondary outcomes

Heart rate variability
Time frame: baseline
Subjective measure of sleepiness
Time frame: baseline

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 23 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site 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 Milton S. Hershey Medical Center at 1 site 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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 23 Apr 2026. 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 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?

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?

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?

Presence of the metabolic syndrome (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT03062748.

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 23 Apr 2026.