跳至主要内容
临床试验/NCT04621032
NCT04621032已完成不适用

Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity

Nowodworskie Centrum Medyczne0 个研究点目标入组 187 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
187
主要终点
A number of patients with visceral obesity and Obstructive Sleep Apnea

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

A number of patients with visceral obesity and Obstructive Sleep Apnea

时间窗: one day per each patient

Polygraphy examination of each patient

次要结局

  • Correlation of Obstructive Sleep Apnea and ECG changes among OSA positive and negative patients(2016-2019)
  • A number of patients with visceral obesity and heart rhythm disorders occurrence.(Holter ECG - one day per patient)

研究者

发起方
Nowodworskie Centrum Medyczne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Jarecka-Dobroń

clinical doctor, PhD

Nowodworskie Centrum Medyczne

相似试验