Obstructive Sleep Apnea (OSA)CPAP-AFNCT07358429
CPAP Therapy and Atrial Fibrillation Recurrence in OSA
An observational study of Obstructive Sleep Apnea (OSA) and Atrial Fibrillation (Paroxysmal), run by Medical University of Sofia at 1 site in Bulgaria.
Trial summary
Obstructive sleep apnea (OSA) is a major modifiable risk factor for atrial fibrillation (AF). Continuous positive airway pressure (CPAP) therapy has been shown to improve cardiovascular outcomes; however, real-world data on its effect on AF recurrence remain limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal)
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Sep 2024to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with moderate-to-severe obstructive sleep apnea and a history of paroxysmal atrial fibrillation, managed in outpatient and hospital settings, and treated with continuous positive airway pressure therapy as part of routine clinical care.
Who may be able to join
- Age ≥ 18 years
- Diagnosed moderate-to-severe OSA
- History of paroxysmal atrial fibrillation
- Ability to initiate CPAP therapy
- Written informed consent -
Who cannot join
- Left ventricular ejection fraction < 50%
- Permanent atrial fibrillation
- Central sleep apnea
- End-stage chronic kidney disease
- Inability to obtain or tolerate CPAP therapy -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of CPAP Therapy on Atrial Fibrillation Recurrence in Patients With Obstructive Sleep Apnea: A Prospective Cohort Study
Obstructive sleep apnea (OSA) is a major modifiable risk factor for atrial fibrillation (AF). Continuous positive airway pressure (CPAP) therapy has been shown to improve cardiovascular outcomes; however, real-world data on its effect on AF recurrence remain limited.
This prospective cohort study aims to evaluate the association between objective CPAP adherence and the risk of AF recurrence in patients with moderate-to-severe OSA and a history of paroxysmal AF.
Patients will be followed for 12 months, with AF recurrence assessed using electrocardiography and Holter monitoring.
Read the detailed description
This is a prospective, real-world cohort study enrolling adult patients with moderate-to-severe obstructive sleep apnea (AHI ≥ 15 events/hour) and documented paroxysmal atrial fibrillation. OSA is diagnosed using home sleep apnea testing.
All participants initiate CPAP therapy, with objective adherence data collected via telemonitoring. Patients are followed for 12 months to assess AF recurrence, progression to permanent AF, and associations with CPAP usage metrics.
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Keywords
- sleep apnea, atrial fibrillation, CPAP therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Atrial Fibrillation, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
CPAP therapy is initiated according to standard clinical practice. Objective adherence data (mean nightly usage, percentage of nights ≥ 4 hours) are collected via telemonitoring systems.
| Study group | Role | What they receive |
|---|---|---|
| High CPAP adherence (≥ 4 h/night) | Participants with mean nightly CPAP use ≥ 4 hours. Receives: Device: Continuous Positive Airway Pressure (CPAP) | |
| Low CPAP adherence (< 4 h/night) | Participants with mean nightly CPAP use < 4 hours. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Recurrence of Paroxysmal Atrial Fibrillation
First documented recurrence of paroxysmal AF confirmed by 12-lead ECG or 24-hour Holter monitoring.
Measured: 12 months
Secondary outcomes (1)
Progression to Permanent Atrial Fibrillation
Progression to Permanent Atrial Fibrillation for 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Sep 2024
- Primary completion30 Nov 2025
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petar Rosenov Kalaydzhiev, Medical University of Sofia
- Investigators
- Petar R Kalaydzhiev, PhD, Principal investigator, Medical University - Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358429
- Sponsor's protocol ID
- MP18/09.08.2024
- Acronym
- CPAP-AF
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to data protection regulations and the absence of explicit participant consent for data sharing beyond the scope of the current study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CPAP Therapy on Atrial Fibrillation Recurrence in Patients With Obstructive Sleep Apnea: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07358429
- Acronym / sponsor ID
- CPAP-AF / MP18/09.08.2024
- Keywords
- sleep apnea, atrial fibrillation, CPAP therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a major modifiable risk factor for atrial fibrillation (AF). Continuous positive airway pressure (CPAP) therapy has been shown to improve cardiovascular outcomes; however, real-world data on its effect on AF recurrence remain limited.
This prospective cohort study aims to evaluate the association between objective CPAP adherence and the risk of AF recurrence in patients with moderate-to-severe OSA and a history of paroxysmal AF.
Patients will be followed for 12 months, with AF recurrence assessed using electrocardiography and Holter monitoring.
Detailed description
This is a prospective, real-world cohort study enrolling adult patients with moderate-to-severe obstructive sleep apnea (AHI ≥ 15 events/hour) and documented paroxysmal atrial fibrillation. OSA is diagnosed using home sleep apnea testing.
All participants initiate CPAP therapy, with objective adherence data collected via telemonitoring. Patients are followed for 12 months to assess AF recurrence, progression to permanent AF, and associations with CPAP usage metrics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High CPAP adherence (≥ 4 h/night) | – | Device: Continuous Positive Airway Pressure (CPAP)Participants with mean nightly CPAP use ≥ 4 hours. |
| Low CPAP adherence (< 4 h/night) | – | Device: Continuous Positive Airway Pressure (CPAP)Participants with mean nightly CPAP use < 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with moderate-to-severe obstructive sleep apnea and a history of paroxysmal atrial fibrillation, managed in outpatient and hospital settings, and treated with continuous positive airway pressure therapy as part of routine clinical care.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosed moderate-to-severe OSA
- History of paroxysmal atrial fibrillation
- Ability to initiate CPAP therapy
- Written informed consent -
Key exclusion criteria (5 listed)
- Left ventricular ejection fraction < 50%
- Permanent atrial fibrillation
- Central sleep apnea
- End-stage chronic kidney disease
- Inability to obtain or tolerate CPAP therapy -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)CPAP therapy is initiated according to standard clinical practice. Objective adherence data (mean nightly usage, percentage of nights ≥ 4 hours) are collected via telemonitoring systems. | Device | High CPAP adherence (≥ 4 h/night), Low CPAP adherence (< 4 h/night) |
Primary outcome
Time to First Recurrence of Paroxysmal Atrial Fibrillation
Time frame: 12 months
First documented recurrence of paroxysmal AF confirmed by 12-lead ECG or 24-hour Holter monitoring.
1 secondary outcome
Progression to Permanent Atrial Fibrillation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to data protection regulations and the absence of explicit participant consent for data sharing beyond the scope of the current study.
Related trials for Obstructive Sleep Apnea (OSA)
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petar R Kalaydzhiev, PhD principal investigator
Medical University - Sofia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Atrial Fibrillation (Paroxysmal), run by Medical University of Sofia at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Recurrence of Paroxysmal Atrial Fibrillation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.