Relationship Between Obstructive Sleep Apnoea and AF.
Ghanshyam Shantha, Frank Pelosi, Fred Morady
https://pubmed.ncbi.nlm.nih.gov/31463055Actively Recruiting
Age: 18Years +
All Genders
ID07259200
Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)
Led by Primula Clinics · Updated on 2025-12-02
100
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying sleep patterns in people with paroxysmal atrial fibrillation who are scheduled for pulmonary vein isolation, a procedure to control heart rhythm. The study aims to see how sleep parameters, especially the apnea-hypopnea index (AHI), change during treatment. This observational study uses polygraphy to monitor sleep without affecting patients' regular care. Participants will undergo four sleep studies using polygraphy to record pulse oximetry, heart rate, chest and abdominal movements, and nasal airflow. Two studies occur before the ablation procedure, spaced at least 7 days apart, and two after the procedure, starting one month later, also spaced by at least 7 days. The ablation itself is a routine clinical procedure and not part of the study. During the study, participants will receive standard care including lifestyle advice and therapies as needed. Researchers will track sleep parameters before and after ablation using certified sleep-monitoring devices. The main outcome is the change in AHI from baseline over about one year. Participation involves non-invasive sleep monitoring and does not interfere with usual treatment, with data protected according to privacy regulations.
CONDITIONS
Brief Title
Impact of Atrial Fibrillation Ablation on Sleep Parameters.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of atrial fibrillation and scheduled catheter ablation
- Presence of at least one obstructive sleep apnea risk factor such as hypertension, male sex, BMI over 25, diabetes, excessive daytime sleepiness, or snoring
You will not qualify if you...
- No presence of any predefined sleep apnea risk factors
- Lack of consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 polygraphic studies performed at least 7 days apart before ablation
Monitoring
Duration - Approximately 1 year
Participants who undergo routine care are observed with polygraphic studies to assess sleep parameters before and after atrial fibrillation ablation.
2 polygraphic studies performed at least 7 days apart starting one month after ablation
Trial Site Locations
Total: 1 location
1
Primula Clinics
Grodzisk Mazowiecki, Poland, 05-825
Actively Recruiting
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Research Team
P
Paweł S Basiukiewicz, MD, PhD
P
Piotr Futyma, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Nightly sleep apnea severity in patients with atrial fibrillation: Potential applications of long-term sleep apnea monitoring.
Dominik Linz, Mathias Baumert, Lien Desteghe...
https://pubmed.ncbi.nlm.nih.gov/317634382024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).
Isabelle C Van Gelder, Michiel Rienstra, Karina V Bunting...
https://pubmed.ncbi.nlm.nih.gov/39210723