Impact of Atrial Fibrillation Ablation on Sleep Parameters. (AAHI)

November 26, 2025 updated by: Primula Clinics

Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)

Assessment of Sleep Parameters Using Polygraphy in Patients with Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study: Afib Ablation and Hypopnea Index - The "AAHI" Study

Principal Investigator:

Dr. Paweł Basiukiewicz, MD, PhD

Study Sponsor:

Primula Clinics sp. z o.o. Żyrardowska 31, 05-825 Grodzisk Mazowiecki, Poland NIP (Tax ID): 529 183 03 11

Dear Sir/Madam,

You have been invited to participate in a scientific study aimed at assessing sleep parameters in patients with atrial fibrillation undergoing rhythm-control therapy. Please read this document carefully before deciding whether to take part in the study. If you have any questions, please contact the principal investigator.

Study Objective:

To assess sleep parameters using polygraphy in the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation.

Study Procedures:

The study involves four polygraphic sleep studies (two before and two after atrial fibrillation ablation), each conducted at least 7 days apart.

The polygraphic studies will record the following parameters: pulse oximetry, heart rate, respiratory movements of the chest, and airflow through the anterior nares.

The study includes only patients undergoing atrial fibrillation ablation for the first time.

Risks and Benefits:

The study is non-invasive and does not involve any direct health risks. Participation will not affect your treatment process, but it may provide valuable information about your health status.

Voluntary Participation:

Participation in the study is entirely voluntary. You may withdraw from the study at any time without providing a reason and without any impact on your ongoing medical treatment.

Personal Data Protection (GDPR):

In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation - GDPR):

The data controller is Primula Clinics sp. z o.o.

Personal data will be processed solely for the purpose of conducting this study.

Data will be stored no longer than required by law or necessary for the research purposes.

You have the right to access your data, request its correction, deletion, restriction of processing, and to object to data processing.

All data will be protected against unauthorized access.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Study Title

Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study: AFib Ablation and Hypopnea Index - The "AAHI" Study

Principal Investigator: Dr. Paweł Basiukiewicz, MD, PhD Study Sponsor: Primula Clinics sp. z o.o. Żyrardowska 31, 05-825 Grodzisk Mazowiecki, Poland NIP (Tax ID): 529 183 03 11

2. Introduction and Study Rationale

Atrial fibrillation (AFib) is the most common cardiac arrhythmia and is associated with an increased risk of cardiovascular complications and reduced quality of life. Obstructive sleep apnea (OSA) frequently coexists with AFib and may influence both the course of the arrhythmia and the effectiveness of its treatment, including catheter ablation. It is known that atrial fibrillation may exacerbate obstructive sleep apnea through mechanisms such as the loss of atrioventricular synchrony, absence of the so-called "atrial kick," tachycardia, and fluid redistribution within the body during AFib episodes.

The aim of this study is to assess changes in sleep parameters, measured by polygraphy, during the treatment course of patients with atrial fibrillation who are qualified for pulmonary vein isolation.

3. Study Objective

To assess sleep parameters using polygraphy during the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation.

4. Research Hypothesis

Sleep parameters assessed via polygraphy, particularly the Apnea-Hypopnea Index (AHI), change following rhythm-control therapy.

5. Study Population

Inclusion Criteria:

Patients with atrial fibrillation who have been previously qualified for AFib ablation.

Presence of at least one risk factor for sleep apnea from the following list: diabetes, hypertension, male sex, BMI > 25, neck circumference > 42 cm in women and > 45 cm in men, upper airway obstruction, history of snoring, daytime sleepiness or fatigue, or witnessed apneic events or choking episodes during sleep.

Exclusion Criteria:

Absence of sleep apnea risk factors.

Lack of consent to participate in the study.

Study Notes:

Polygraphic assessments will be performed as a standard procedure recommended in clinical guidelines, ensuring that the study does not interfere with routine patient care.

Therefore, the study maintains an observational, non-interventional character.

6. Study Procedures

  1. Before the planned AFib ablation:

    Two polygraphic studies will be performed at least 7 days apart.

    Recorded channels: pulse oximetry, heart rate, respiratory movements of the chest and abdomen using respiratory inductance plethysmography (RIP) belts, and nasal airflow (pressure) through the anterior nares.

  2. After AFib ablation:

    Two polygraphic studies will be performed, at least 7 days apart, beginning one month after the ablation procedure.

    The same recording channels as above will be used.

  3. Routine recommendations:

    All standard-of-care procedures, including lifestyle modification advice and non-pharmacological interventions (e.g., initiation of CPAP therapy, if indicated), will be provided to each patient in accordance with routine clinical practice.

  4. Ablation procedure:

The ablation is not part of the study. It is a pre-planned, routine clinical procedure scheduled prior to study screening.

7. Methodology

Polygraphic Studies:

Certified sleep-monitoring equipment will be used (Nox polygraph, Nox Medical).

Analysis will include AHI, oxygen saturation, heart rate, and respiratory pattern assessment.

Planned Study Population: Approximately 100 participants.

Study Duration: Recruitment period estimated at 6-12 months, with the possibility of extension and inclusion of additional centers if the necessary criteria are met.

Statistical Analysis:

Comparison of pre- and post-ablation sleep parameters using appropriate statistical tests (e.g., paired t-test for parametric data or Wilcoxon test for non-parametric data).

Endpoints: Statistically significant changes in sleep parameters (particularly AHI) recorded by polygraphy.

8. Ethics

The study is observational and does not interfere with standard patient treatment.

All participants will provide written informed consent after being informed about the purpose, course, and potential benefits of the study.

The study will be conducted in accordance with the Declaration of Helsinki and approved by the local bioethics committee.

9. Results and Application

The study results may provide insight into the potential effects of rhythm-control therapy on sleep parameters in patients with atrial fibrillation. This could contribute to a better understanding of the relationship between these two conditions and to optimizing patient management.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Grodzisk Mazowiecki, Poland, 05-825
        • Recruiting
        • Primula Clinics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with AFib scheduled for pulmonary vein isolation.

Description

Inclusion Criteria (all must be met):

  • Diagnosis of atrial fibrillation (AFib) and scheduled catheter ablation.
  • Presence of at least one OSA risk factor: hypertension, male sex, BMI > 25, diabetes, excessive daytime sleepiness, snoring.

Exclusion Criteria:

- Absence of predefined sleep apnea risk factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Afib scheduled for PVI, at least one risk factor for obstructive sleep apnea.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from the baseline in post ablation apnea-hypopnea index (AHI)
Time Frame: From baseline through study completion, an average of 1 year
Change in apnea - hypopnea index after atrial fibrillation ablation (pulmonary vein isolation). Improvement will be assessed as a decrease in the Apnea-Hypopnea Index.
From baseline through study completion, an average of 1 year
apnea - hypopnea index (AHI) change
Time Frame: From baseline through study completion, an average of 1 year
Assessment of change of AHI post PVI procedure.
From baseline through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Primula Clinics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paweł S Basiukiewicz, MD, PhD, Primula Clinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KB/1641/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Database with participants (DOB, HSAT data, PVI date and echocardiograhy findings)

IPD Sharing Time Frame

01.01.2026 till 01.01.2027

IPD Sharing Access Criteria

Investigators with granted permission from PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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