The Correlation Between Obstructive Sleep Apnea-Related Nocturnal Hypoxemia Parameters and Coronary Microvascular Dysfunction: A Prospective Cohort Study (SLEEP-CMD) (SLEEP-CMD)

December 18, 2025 updated by: Beijing Anzhen Hospital

The Correlation Between Obstructive Sleep Apnea-Related Nocturnal Hypoxemia Parameters and Coronary Microvascular Dysfunction: A Prospective Cohort Study

In a cohort of patients with suspected myocardial ischemia undergoing sleep studies, the objectives of this study were:

  1. To determine the association between various obstructive sleep apnea (OSA)-related nocturnal hypoxemia parameters and coronary microvascular dysfunction (CMD) in patients with suspected myocardial ischemia.
  2. To compare the predictive value of nocturnal hypoxemia parameters versus the traditional Apnea-Hypopnea Index (AHI) for coronary microvascular dysfunction.
  3. To evaluate the prognostic value of nocturnal hypoxemia parameters in predicting Major Adverse Cardiovascular Events (MACE) during the follow-up period.
  4. To explore the potential mediating roles of inflammatory and oxidative stress biomarkers in the relationship between nocturnal hypoxemia parameters and coronary microvascular dysfunction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronary Microvascular Dysfunction (CMD) constitutes the core pathological mechanism underlying Ischemia with Non-Obstructive Coronary Arteries (INOCA) and serves as a significant etiological factor in Ischemic Heart Disease (IHD). CMD exhibits a high prevalence within the cardiovascular disease population and is significantly associated with the risk of Major Adverse Cardiovascular Events (MACE). A meta-analysis has demonstrated that all-cause mortality in patients with CMD is 3.93 times higher than in the non-CMD population, with a 5.16-fold increase in the risk of MACE. Obstructive Sleep Apnea (OSA) is a highly prevalent sleep-disordered breathing condition, affecting approximately 936 million people globally and 176 million adults in China. As a critical cardiovascular comorbidity, OSA has a detection rate as high as 50%-83% among patients with Cardiovascular Disease (CVD) and is closely related to the development and progression of heart failure and atrial fibrillation. OSA can significantly promote the onset and progression of CMD through intermittent hypoxia-induced oxidative stress, the release of pro-inflammatory cytokines, and enhanced sympathetic nervous activity. Therefore, exploring the interaction mechanisms between CMD and OSA holds significant clinical value.

The core pathological features of CMD involve structural remodeling and functional abnormalities of the coronary microvasculature. The gold standard for its diagnosis is the Index of Microvascular Resistance (IMR) measured via an invasive pressure wire; however, this procedure is complex. In contrast, the Angiography-derived Index of Microvascular Resistance (Angio-IMR) is simple to perform, and numerous clinical studies have confirmed its high consistency with invasive IMR. Currently, an Angio-IMR >25 U is considered the cutoff value for diagnosing CMD. The typical clinical presentation of OSA includes habitual snoring, morning fatigue, excessive daytime sleepiness, and sleep fragmentation. Its diagnosis relies on Polysomnography (PSG), and disease severity is quantified and graded using the Apnea-Hypopnea Index (AHI).

Previous studies have confirmed an independent correlation between OSA and CMD; however, existing evidence is largely based on single assessments using the AHI, lacking a systematic analysis of hypoxemia characteristics. While AHI reflects the overall frequency of respiratory events, it cannot effectively distinguish the severity, duration of exposure, and frequency of hypoxemia. Existing evidence suggests that at identical AHI levels, the 5-year incidence of cardiovascular events can differ by up to 2.3-fold among patients with different hypoxia patterns. Furthermore, intervention strategies based solely on AHI have shown limited efficacy in improving all-cause mortality in CVD patients with comorbid OSA. Our team's preliminary retrospective cohort study indicated that the minimum oxygen saturation (minSpO2) ≤90% and the time with oxygen saturation below 90% (T90) were independently associated with CMD, whereas no significant correlation was found between AHI and CMD. This suggests that nocturnal hypoxemia parameters may offer superior predictive value for OSA-related CMD risk compared to the traditional AHI metric. However, clear evidence regarding the dose-response relationship between hypoxic parameters and CMD is currently lacking, and the specific impact of different hypoxic patterns (intermittent vs. sustained hypoxia) on the pathogenesis of CMD remains unelucidated. This limits the precise risk stratification and the formulation of individualized intervention strategies for CMD in OSA patients. Therefore, this study proposes a prospective cohort study to systematically evaluate the association and mechanisms between OSA-related nocturnal hypoxemia parameters and CMD. The aim is to construct a cardiovascular risk stratification model for OSA patients based on hypoxic characteristics, providing a scientific basis for implementing personalized targeted interventions, and ultimately improving patients' clinical prognosis and health-related quality of life.

The current study will be conducted by the National clinical research center for cardiovascular disease at multiple collaborating centers across China.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Suspected myocardial ischemia patients underwent PSG to acquire detailed parameters of OSA-related nocturnal hypoxemia.

Description

Inclusion Criteria:

  1. Aged 18 to 80 years, of any gender.
  2. Scheduled for elective coronary angiography due to symptoms or evidence of myocardial ischemia.
  3. Agreed to and capable of completing overnight polysomnography (PSG) monitoring.
  4. Provided written informed consent and were willing and able to comply with baseline assessments and long-term follow-up.

Exclusion Criteria:

  1. Presence of coronary chronic total occlusion (CTO), history of coronary artery bypass grafting (CABG), severe valvular heart disease, dilated or hypertrophic cardiomyopathy, congenital heart disease, or heart failure (NYHA functional class III-IV).
  2. Sleep-disordered breathing with central sleep apnea (CSA) as the primary manifestation.
  3. Severe hepatic insufficiency (Child-Pugh class C) or renal failure (eGFR < 30 mL/min/1.73 m²).
  4. Pregnancy or lactation.
  5. Life expectancy of less than 2 years, or any other condition that the investigators considered unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the Prevalence of CMD Among Patients with OSA of Different Severities
Time Frame: at 6, 12, and 24 months after discharge
Differences in the Prevalence of Coronary Microvascular Dysfunction Among Patients with Obstructive Sleep Apnea of Different Severities
at 6, 12, and 24 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The composite endpoint of major adverse cardiovascular events (MACE)
Time Frame: At 6, 12, and 24 months after discharge
including cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina or heart failure.
At 6, 12, and 24 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BeijingAnzhen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to patient privacy and ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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