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

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ClinicalTrials.gov Identifier: NCT03479788
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
National Heart Centre Singapore
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore

Brief 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.


Condition or disease
Obstructive Sleep Apnea Diabetes Mellitus Coronary Artery Disease

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.


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Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep and Stent Study II - Rapid Eye Movement Related Obstructive Sleep Apnea in Diabetic Versus Non-Diabetic Patients Treated With Percutaneous Coronary Intervention
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



Primary Outcome Measures :
  1. REM OSA [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone clinically indicated PCI between 6 and 36 months ago
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479788


Locations
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Singapore
Lee Chi-Hang Ronald
Singapore, Singapore, 119228
Sponsors and Collaborators
National University, Singapore
National Heart Centre Singapore

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Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT03479788     History of Changes
Other Study ID Numbers: Sleep and Stent Study II
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi-Hang Lee, National University, Singapore:
sleep apnea, coronary artery, diabetes
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases