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

Sleep and Stent Study II - Rapid Eye Movement Related Obstructive Sleep Apnea in Diabetic Versus Non-Diabetic Patients Treated With Percutaneous Coronary Intervention

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Diabetes Mellitus; Obstructive Sleep Apnea

Detailed Description

The Sleep and Stent II is a cross-sectional study of patients who have undergone PCI for coronary artery disease. A total of 200 adult patients who have undergone clinically indicated PCI between 6 and 36 months ago are eligible. The study involves the 2 national heart centers and the Ng Teng Fong General Hospital in Singapore (3 centers in total). The National University Heart Center Singapore is the leading center and it is responsible for the overall study design and study conduct. The estimated duration of the Sleep and Stent II is 3 years (2018-2020).

All subjects and/or their legally authorized representative must provide written informed consent before any study-related procedure can be conducted. The patients will be divided into DM and non-DM groups, and the two groups will be matched for age, sex, and BMI. As a standard clinical practice in Singapore, patients who have undergone PCI will be followed up at the outpatient clinic for continuation of care. As such, the recruitment will be conducted at the outpatient clinic. All recruited patients will undergo an overnight polysomnography at the National University Health System Cardiosleep research laboratory.

All polysomnography studies will be conducted using a standardized level I diagnostic device (Embla RemLogic, Natus Medical Inc. Canada). Outputs recorded from the portable diagnostic device will be manually scored by an independent sleep technologist with Registered Polysomnographic Technologist credentials, blinded to the patients' clinical characteristics.

The primary measure of the polysomnography will be the AHI, quantified as the total number of apneas and hypopneas per hour of sleep. An apnea is defined as a 90% or greater decrease in airflow from the baseline value for at least 10 seconds. Apneas are further classified as obstructive or central based on the presence or absence, respectively, of respiratory-related chest wall movement. Hypopnea is defined as a 30-90% reduction in airflow from the baseline value lasting 10 seconds or more, in conjunction with ≥3% oxygen desaturation. The respiratory event scoring will be performed according to the American Academy of Sleep Medicine guidelines. For all patients the AHI during total sleep time, the AHI during REM (AHI-REM), and the AHI during non-REM sleep (AHI-NREM) will be calculated. REM OSA is defined in a variety of ways including AHI at least 5 withAHI-REM/AHI-NREM ratio at least 2; overall AHI at least 5 with AHI-REM/ AHI-NREM ratio at least 2 and with AHI-NREM less than 15; overall AHI at least 5, AHI-REM/AHI-NREM ratio at least 2 and with AHI-NREM less than 8.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119228
    • Lee Chi-Hang Ronald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone clinically indicated PCI between 6 and 36 months ago

Description

Inclusion Criteria:

Age >21 years old Have undergone clinically indicated PCI between 6 and 36 months ago

Exclusion Criteria:

Known OSA on treatment Clinical instability with admission for acute coronary syndrome, heart failure or stroke in the past 30 days Inability to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
DM; Observational study. NO intervention
non-DM; Observational study. NO intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
REM OSA	The primary measure of the polysomnography will be the AHI, quantified as the total number of apneas and hypopneas per hour of sleep. An apnea is defined as a 90% or greater decrease in airflow from the baseline value for at least 10 seconds. Apneas are further classified as obstructive or central based on the presence or absence, respectively, of respiratory-related chest wall movement. Hypopnea is defined as a 30-90% reduction in airflow from the baseline value lasting 10 seconds or more, in conjunction with =3% oxygen desaturation. The respiratory event scoring will be performed according to the American Academy of Sleep Medicine guidelines. For all patients the AHI during total sleep time, the AHI during REM (AHI-REM), and the AHI during non-REM sleep (AHI-NREM) will be calculated.	1 day

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: National Heart Centre Singapore

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: sleep apnea, coronary artery, diabetes
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Coronary Disease; Coronary Artery Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Sleep and Stent Study II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No