Could a silent nerve problem mask deadly heart risks in sleep apnea patients?

NCT ID NCT07723222

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First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This observational study investigates whether cardiac autonomic neuropathy (nerve damage affecting the heart) changes the risk of death and cardiovascular events in people who have diabetes, coronary heart disease, and sleep apnea. Researchers will follow 326 participants, dividing them into groups based on nerve function, to see if those with nerve damage face different outcomes. The goal is to understand if the typical warning sign of a slow heart rate is absent in these patients, potentially hiding their risk of sudden cardiac death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this study clarifies the link, it could help identify high-risk patients who might otherwise be overlooked, potentially reducing sudden cardiac deaths.
What could go wrong
This is an observational study, not a treatment trial, so it cannot prove cause and effect. Results may not apply to broader populations.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 326 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Effect of autonomic neuropathy status on end point events in type 2 diabetes patients with coronary heart disease and sleep apnea.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The patient was diagnosed with coronary heart disease (coronary angiogram showed coronary artery stenosis ≥ 50%), diabetes (fasting blood glucose ≥ 7 mmol/L, blood glucose ≥ 11.1 mmol/L 2 hours after OGTT meal, HbA1c ≥ 6.5%, or random blood glucose ≥ 11.1 mmol/L), and sleep apnea syndrome (≥ 5 apnea or hypoventilation events per hour during sleep, that is, AHI ≥ 5 times/hour, with associated symptoms or health risks. ). Exclusion Criteria: * Patients who have been implanted with permanent pacemakers; Patients with severe arrhythmia or myocardial infarction/stroke in the past 3 months; 48 hours prior to the experiment, the use of beta blockers, beta agonists ACE-I、ARB、 Patients with drugs such as adrenaline and dopamine; Pregnant women; Patients with serious diseases of important organs (such as heart, brain, kidney, liver, etc.); Patients with mental or physical disabilities; Unable to cooperate with patients undergoing examinations; Suspected or diagnosed patients with a history of alcohol or drug abuse; Patients with acute complications of diabetes, such as DKA, hypertonic coma, lactic acidosis, etc; Patients with thyroid dysfunction; Patients at risk of cardiac autonomic neuropathy (CAN), such as those with severe hypertension or proliferative retinopathy; Patients with electrolyte disorders such as hypokalemia.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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