CPAP in AF Patients With OSA

NCT04513483 | Completed

• 1 other identifier: 202002128RINC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea is associated with atrial fibrillation. This study is to evaluate the effect of continuous positive airway pressure on the burden of atrial fibrillation in the patients with obstructive sleep apnea and paroxysmal atrial fibrillation.

Conditions

Atrial Fibrillation; Sleep Apnea

Keywords

Atrial Fibrillation; sleep apnea

Outcome Measures

Primary Outcomes (4)

• Change of AF burden

  The duration in AF on 14-day ECG monitor (percent)

  0, 6, 12 months

• change of left atrium volume

  LA volume index measured by ultrasonocardiography

  0, 6, 12 months

• change of Quality of Life

  Questionnaire (Short Form Health Survey-36); higher scores means a better quality of life; maximal score 100%

  0, 6, 12 months

• Number of participants hospitalized for cardiovascular or all causes

  Hospitalization for cardiovascular or all causes within the follow-up period

  12 months

Study Arms (2)

CPAP treatment for 12 months

EXPERIMENTAL

CPAP treatment for 12 months

Device: continuous positive airway pressure

Placebo

PLACEBO COMPARATOR

observation

Device: Placebo

Interventions

continuous positive airway pressure DEVICE

CPAP treatment at night. Treat AF as cardiologist's discretion.

CPAP treatment for 12 months

Placebo DEVICE

Observation. Treat AF as cardiologist's discretion.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men or women aged 18 to 80 years
• paroxysmal AF, diagnosed based on the ACC/AHA/HRS 2014 guideline, and is defined as AF that terminates spontaneously or with intervention within 7 d of onset either by 12-lead EKG, 24-hr Holter, or 14-day ECG monitor.
• OSA, defined as an AHI\>15/hr of sleep, of which \>50% of events are obstructive.
• Informed consent signed

You may not qualify if:

• Moderate-severe valvular heart diseases (regurgitation or stenosis)
• post heart surgery
• Uncontrolled systemic hypertension or pulmonary hypertension
• Use of psychoactive or other drugs that could influence breathing patterns
• Current use of CPAP treatment
• Epworth sleepiness scale\>10
• Congestive heart failure (LVEF≦45%)
• Chronic obstructive pulmonary disease
• History of stroke or neuromuscular disease
• Severe insomnia

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Chih-Chieh Yu, MD.PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 14, 2020
• Study Start: August 7, 2020
• Primary Completion: August 6, 2025
• Study Completion: August 31, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)