An observational study in Coronary Heart Disease, Diabetes and Sleep Apnea Syndrome, sponsored by Xiangtan Central Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Xiangtan Central Hospital · Observational
Background: diabetes combined with cardiac autonomic neuropathy (CAN) can denervate the heart, which may prevent patients with sleep apnea syndrome from bradycardia in the early stage, and directly show an increased risk of tachyarrhythmia and sudden cardiac death. This means that many diabetes patients with sleep apnea syndrome who are at risk of sudden death may be ignored due to the lack of the typical signal of "bradycardia". A study showed 299 events among 165 participants, of which 132 participants (10%) had CAN and experienced 244 cardiovascular events, and 33 participants (25%) had CAN and experienced 55 cardiovascular events (hazard ratio [HR] 2.79, 95% CI 1.91). In this trial, the effect of autonomic neuropathy on the end point events of type 2 diabetes patients with coronary heart disease and sleep apnea was investigated.
Objective: This study is a prospective, single-center, observational study to investigate the effect of autonomic neuropathy status on the endpoint events in patients with coronary heart disease, diabetes, and sleep apnea syndrome.
Methods : Diagnosed coronary heart disease (coronary angiography 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), sleep apnea syndrome (≥ 5 apnea or hypoventilation events per hour during sleep (AHI ≥ 5 times/hour), and associated symptoms or health risks. ）The patient. The Ewing test was divided into two groups: the group without concomitant cardiac autonomic neuropathy and the group with cardiac autonomic neuropathy. The primary endpoint includes all-cause mortality events during follow-up, and the secondary endpoint includes the occurrence of cardiovascular events.
This study will explore the influence of autonomic neuropathy on the endpoint events of patients with diabetes, coronary heart disease and sleep apnea.
Keywords: coronary heart disease, diabetes, sleep apnea syndrome, cardiovascular autonomic neuropathy, results
2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.
This study's planned enrollment of 326 is below the median of 460 across 953 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Xiangtan Central Hospital is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Effect of autonomic neuropathy status on end point events in type 2 diabetes patients with coronary heart disease and sleep apnea.
Exclusion Criteria:
Cardiovascular autonomic neuropathy group
Behavioral: The total score of Ewing test (i.e. cardiovascular autonomic reflex test and heart rate variability) was ≥1, which was divided into cardiac autonomic neuropathy group (CAN grou
Non-Cardiovascular autonomic neuropathy group
Avoid vigorous exercise the day before and on the day of the test. Avoid strong tea, coffee, and alcohol for at least 2 hours before the test. Conduct the test 2 hours after meals and rest in bed for at least 20 minutes. Each test should be conducted with a 5-minute interval Vagus nerve function test (mainly affecting heart rate) Heart rate response in supine position (30:15 ratio): * Operation: The subject actively stands up from the supine position and records the electrocardiogram. * Calculation: Divide the longest RR interval near the 30th heartbeat after standing by the shortest RR interval near the 15th heartbeat. * Interpretation: Normal ≥ 1.04, critical 1.01-1.03, abnormal ≤ 1.00. Deep breath heart rate response (breathing difference): * Operation: Take deep breaths at a rate of 6 times per minute (5 seconds for each inhalation and exhalation) for 1 minute. * Calculation: The average of the maximum heart rate minus the minimum heart rate per minute. * Interpretation: Normal
All-cause death event
Time frame: Follow up endpoint events after 3 years of enrollment.
cardiovascular events
Time frame: Follow up endpoint events after 3 years of enrollment.
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Xiangtan Central Hospital