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Rapid Eye Movement Related OSA in Diabetic Versus Non-Diabetic Patients Treated With PCI

NCT03479788 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 204

Last updated 2020-03-26

No results posted yet for this study

Summary

The primary objective of the Sleep and Stent II is to determine the prevalence of REM-OSA in DM versus non-DM patients undergoing clinically indicated PCI.

The secondary objectives are to investigate the association between REM-AHI and (1) cardiac arrhythmia based on ambulatory ECG monitoring, (2) excessive daytime sleepiness, and (3) glycemic control in patients with DM.

In addition, we will determine the prevalence of REM-OSA based on alternative definitions, including (a) overall AHI at least 5 with AHI REM/AHI NREM ratio at least 2; (b) overall AHI at least 5 with AHI REM/AHI NREM ratio at least 2 and with AHI NREM \< 15; (c) overall AHI at least 5, AHI REM/AHI NREM ratio at least 2 and with AHI NREM \< 8.

Conditions

Sponsors & Collaborators

Eligibility

Min Age
22 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479788 on ClinicalTrials.gov