Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity

Obstructive Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621032
• Other study ID #: 1
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2020
• Source: Nowodworskie Centrum Medyczne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Arrhythmias, Cardiac
• Heart Rhythm Disorder
• Obesity, Abdominal
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• laboratory tests
Blood samples for sodium, potassium, calcium, magnesium concentration and fasting glyceamia assessment hae been taken from all patients with visceral obesity.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nowodworskie Centrum Medyczne	Medical University of Warsaw

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A number of patients with visceral obesity and Obstructive Sleep Apnea	Polygraphy examination of each patient	one day per each patient
Secondary	A number of patients with visceral obesity and heart rhythm disorders occurrence.	Holter-ECG monitoring of each patient	Holter ECG - one day per patient
Secondary	Correlation of Obstructive Sleep Apnea and ECG changes among OSA positive and negative patients	statistical analysis	2016-2019