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Influence of Sleep Apnea on Risk of Atrial Fibrillation

NCT02576587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2018-08-15

Study results available
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Summary

The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study.

The study involves a case control design to investigate the extent to which there is an independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and controls as those without AF. In order to rigorously address important biologic confounding influences, the cases and controls will be individually matched based upon age, gender, race, and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI\>=15) will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical Research Unit (CRU) for collection of the same measures collected at the baseline exam to observe for any significant changes with the purpose of collecting effect size data to inform future clinical trials.

The total duration of the study is 4 years. The duration for any individual participant is up to from one to 13 weeks months, including a 3-month treatment period for those with moderate to severe SDB, i.e. AHI\>15.

Conditions

Interventions

OTHER

Continuous Positive Airway Pressure

For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Reena Mehra, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2017-02-22
Completion
2017-02-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576587 on ClinicalTrials.gov