Electrocardiography Data Analysis in Sleep Disorders

NCT02188498 | Completed

• 1 other identifier: Electrocardiography Study
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if a non-invasive technique, using an innovative analysis of electrocardiogram (ECG) data, would allow for detection of respiratory events during sleep and discrimination between central and obstructive apnea. Obstructive Sleep Apnea (OSA) is the most common respiratory disturbance seen during sleep, with an estimated prevalence of 10 % in the population and is strongly associated with the development of cardiovascular disease. In patients with underlying cardiac disease, particularly in heart failure (HF), central respiratory events such as Cheyne-Stokes Respiration (CSR) are often seen during sleep. The presence of CSR is also associated with increased cardiovascular morbidity and mortality. Currently, the identification and classification of sleep related respiratory disturbances is performed during over-night sleep studies (polysomnography), which are labor-intensive, time-consuming, expensive and difficult for patients. Thus, the development of alternative techniques to assist in the identification of those events in the outpatient setting is of marked importance for widespread screening of sleep apnea.

Conditions

Sleep Disorders; Sleep Apnea; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  The variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval.

  One night of sleep study

Secondary Outcomes (2)

• Analysis of QRS morphology

  One night of sleep study

• electrocardiogram signal

  One night of sleep study

Study Arms (1)

Polysomnography with Holter monitoring

Patients will undergo resting electrocardiogram (ECG) test at the beginning of the night and be monitored by a Holter device for the duration of the sleep study.

Procedure: Polysomnography

Interventions

Polysomnography PROCEDURE

Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study.

Polysomnography with Holter monitoring

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing overnight sleep studies

You may qualify if:

• Patients presenting to the WCMC Sleep Center for polysomnography

You may not qualify if:

• N/A

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Center for Sleep Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Ana Krieger, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 11, 2014
• Study Start: September 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)