Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity

November 24, 2020 updated by: Aleksandra Jarecka-Dobroń, Nowodworskie Centrum Medyczne

Literature shows that patients with obesity and Obstructive Sleep Apnea (OSA), both occurring independently, are more likely to develop cardiovascular diseases and sudden cardiac death (SCD). Assuming that ventricular depolarization is more stable than repolarization then QT interval parameters may be used for heart muscle repolarization assessment for those groups of patients.

There were 121 patients included in the study, both - women and men, aging from 35-65 with visceral obesity. Only healthy patients were included - the ones who were not treated for any chronic disease, taking QT elongating drugs, or were not treated with Continuous Positive Airway Pressure (CPAP) therapy at that time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current study was a prospective, observational clinical trial performed between September 2016 and August 2019 at a single-center institution specializing in treatment of patients with obstructive sleep apnea. The inclusion criteria were as follows: (1) gender: female or male, (2) age 35-65 years old, (3) visceral obesity, (4) lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders, (5) not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration [according to Credible Meds list (Woosley et al, 2019)], (6) not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination. Patients, who met all inclusion criteria, underwent subject and physical examination, an over-night Holter-ECG, polygraphy and laboratory biochemical tests (sodium, potassium, calcium, magnesium concentration and fasting glyceamia.

Enrolled patients were asked questions about general frame of mind, daytime and nighttime symptoms that may suggest OSA [according to Epworth Sleepiness Scale (https://epworthsleepinessscale.com/about-the-ess/ access date 08 May 2020)]. All patients were fully physically examined. Neck and waist circumference were measured according to STEPwise Approach to Surveillance (STEPS) by WHO (https://www.who.int/ncds/surveillance/steps/en/. [access date 23 April.2019]. Upon subject examination (snoring and choking feeling during the sleep) a corrected neck circumference was calculated.

Polygraphy was conducted using MED Recorder device by Infoscan company according to AASM guidelines (American Academy of Sleep Medicine, International classification of sleep disorders, 2016). The device registered blood saturation, heart rate, airflow, chest and abdomen movements, body position, snoring and single lead ECG. OSA was diagnosed according to AASM definition (American Academy of Sleep Medicine, Sleep-related breathing disorders in adults, 1999): in every patient with Respiratory Disturbance Index (RDI) ≥ 5/hour and with concomitant OSA sings (Epworth Sleepiness Scale ≥ 11 pts) or with RDI ≥ 15/hour. The minimum time of analyzed data without artifacts had to last at least 6 h.

A Holter-ECG examination was conducted using DMS 300-3A device by Oxford company suitable for Cardioscan 10 system. Registration was made simultaneously with polygraphy, during the night. Chosen QT interval assessment parameters were evaluated upon partially automatically analyzed fragments of ECG records. Only nighttime ECG records were analyzed due to maximum comparability (similar patient's physical activity and minimized, because of limited body movements, artifacts). Moreover, the study aimed to assess a heart's activity simultaneous to sleep breathing disorders. Only ECG strips with constant heart rate, optimally within 50-70/min limits, were chosen due to the minimum impact of such heart rate on QT interval correction formula. QTc data was calculated upon Bazett's formula. QTV and QTVi were calculated upon Berger's formula.

After getting all results they were checked against the following exclusion criteria: 1) revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics, 2) revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg, 3) revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible, 4) too short total sleep time (< 6 hours) registered on polygraphy.

Out of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses.

Study Type

Observational

Enrollment (Actual)

187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Out of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses.

Description

Inclusion Criteria:

  • gender: female or male,
  • age 35-65 years old,
  • visceral obesity,
  • lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders,
  • not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration [according to Credible Meds list (Woosley et al, 2019)],
  • not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination.

Exclusion Criteria:

  • revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics,
  • revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg,
  • revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible,
  • too short total sleep time (< 6 hours) registered on polygraphy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSA +
Patients with visceral obesity and newly diagnosed Obstructive Sleep Apnea (during the study)
Diagnostic test: Polygraphy monitoring
All patients with visceral obesity have been tested for Obstructive Sleep Apnea and heart rhythm disorders by usage of polygraphy and Holter-ECG monitoring.
Other Names:
  • Holter ECG monitoring
Diagnostic test: laboratory tests
Blood samples for sodium, potassium, calcium, magnesium concentration and fasting glyceamia assessment hae been taken from all patients with visceral obesity.
OSA -
Patients with visceral obesity in whom Obstructive Sleep Apnea diagnosis have been excluded (during the study)
Diagnostic test: Polygraphy monitoring
All patients with visceral obesity have been tested for Obstructive Sleep Apnea and heart rhythm disorders by usage of polygraphy and Holter-ECG monitoring.
Other Names:
  • Holter ECG monitoring
Diagnostic test: laboratory tests
Blood samples for sodium, potassium, calcium, magnesium concentration and fasting glyceamia assessment hae been taken from all patients with visceral obesity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A number of patients with visceral obesity and Obstructive Sleep Apnea
Time Frame: one day per each patient
Polygraphy examination of each patient
one day per each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A number of patients with visceral obesity and heart rhythm disorders occurrence.
Time Frame: Holter ECG - one day per patient
Holter-ECG monitoring of each patient
Holter ECG - one day per patient
Correlation of Obstructive Sleep Apnea and ECG changes among OSA positive and negative patients
Time Frame: 2016-2019
statistical analysis
2016-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nowodworskie Centrum Medyczne

Collaborators

Medical University of Warsaw

Investigators

  • Principal Investigator: Aleksandra Jarecka-Dobroń, PhD, NowodworskieMD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 24, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For a reasonable request the principal intevstigator will share stastical data of studied group.

IPD Sharing Time Frame

As soon as posible after getting the request.

IPD Sharing Access Criteria

All requests will be considered by the main investigator and data will be send to the indicated e-mail.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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