Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity

NCT04621032 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 187
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obstructive Sleep Apnea; Heart Rhythm Disorder; Obesity, Abdominal

Keywords

Obstructive Sleep Apnea; QT interval; QTV; QTc; repolarisation homogeneity

Outcome Measures

Primary Outcomes (1)

• A number of patients with visceral obesity and Obstructive Sleep Apnea

  Polygraphy examination of each patient

  one day per each patient

Secondary Outcomes (2)

• A number of patients with visceral obesity and heart rhythm disorders occurrence.

  Holter ECG - one day per patient

• Correlation of Obstructive Sleep Apnea and ECG changes among OSA positive and negative patients

  2016-2019

Study Arms (2)

OSA +

Patients with visceral obesity and newly diagnosed Obstructive Sleep Apnea (during the study)

Diagnostic Test: Polygraphy monitoring; Diagnostic Test: laboratory tests

OSA -

Patients with visceral obesity in whom Obstructive Sleep Apnea diagnosis have been excluded (during the study)

Diagnostic Test: Polygraphy monitoring; Diagnostic Test: laboratory tests

Interventions

Polygraphy monitoring DIAGNOSTIC_TEST

All patients with visceral obesity have been tested for Obstructive Sleep Apnea and heart rhythm disorders by usage of polygraphy and Holter-ECG monitoring.

Also known as: Holter ECG monitoring

OSA +; OSA -

laboratory tests DIAGNOSTIC_TEST

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

OSA +; OSA -

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nowodworskie Centrum Medyczne: lead
• Medical University of Warsaw: collaborator

Related Publications (26)

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  BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity, Abdominal

Interventions

Electrocardiography, Ambulatory; Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Aleksandra Jarecka-Dobroń, PhD

  NowodworskieMD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor, PhD

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: September 1, 2016
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: As soon as posible after getting the request.
• Access Criteria: All requests will be considered by the main investigator and data will be send to the indicated e-mail.