Atrial Fibrillation ParoxysmalSLEEP-AFNCT04606693
Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates
A study testing Treatment of SAHS in people with Atrial Fibrillation Paroxysmal and Atrial Fibrillation, Persistent, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
The present prospective cohort study (not randomized) analyses the value of screening and treatment of SAHS in the management of patients with AF refractory to antiarrhythmics drugs, potentially candidates for ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Apnea Syndrome
- What is being tested?
- Treatment of SAHS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2020to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients with paroxysmal or persistent atrial fibrillation
- Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic
- No previous diagnosis of apnea-hypopnea syndrome
Who cannot join
- Patients <18 years
- Pregnant women
- Doubts about the patient's ability to perform a home respiratory polygraphy
- Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required)
- Unavailability for follow-up at our center for at least 1 year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Nicasio Pérez-Castellano, MDhPhD, +34913303000 ext. 7278, dr.npc.clinical.trials@gmail.com
Norberto Torres-Esquivel, MD
About this study
Official title: Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates
The present prospective cohort study (not randomized) analyses the value of screening and treatment of SAHS in the management of patients with AF refractory to antiarrhythmics drugs, potentially candidates for ablation.
Patients at low risk of suffering from SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit. Patients with high or intermediate risk of SAHS, will undergo respiratory polygraphy. If the result is positive, they will be treated as standard for this syndrome and their heart rate will be monitored for 3 months. After this, the patient's arrhythmic load will be reevaluated differentiating patients into two groups, those that must be ablated from those that have improved their condition and the clinical criteria is no longer ablation but follow-up.
Read the detailed description
All patients who meet all the inclusion criteria and none of the exclusion will have a Stop-Bang questionnaire to define the risk of having a SAHS The assessment of results classifies people at high, intermediate or low risk of SAHS. Low-risk patients will follow conventional management according to the usual criteria of the Arrhythmia Unit.
Patients with high or intermediate-risk will be given a Kardia© recorder and they will be instructed to obtain records of their cardiac rhythm every 5 days (at any time) and whenever the symptoms are suggestived of arrhythmia. This allows estimating arrhythmic load baseline in these patients.
They will also will be given a 7-channel home respiratory polygraphy (with pulse oximetry record, naso-buccal air flow through nasal cannula and thermistor, snoring, thoracoabdominal movements and electrocardiogram). The day after conducting the home polygraphic record, the patient will be evaluated in the Pneumology Outpatient Department, where risk factors, symptoms and Epworth's sleepiness scale will be assessed, the results of the cardiorespiratory polygraphic record, interpreted by Pneumology Service will be given , and based on the above, the diagnosis of SAHS will be determined.
Those patients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.).
During all this time, patients will continue using their rhythm recorders as previously. The overall effect of SAHS treatment on AF recurrences (comparison of arrhythmic load in the previous 3 months with that of the 3 months post-treatment) will be evaluated.
After 3 months of starting the treatment, a follow-up respiratory polygraphy will be carried out, where the relationship between the changes in AHI and desaturation index as well as changes in arrhythmic load will be evaluated.
Once the follow-up respiratory polygraphy is performed, the indication of AF ablation will be reassessed. Patients who continue with symptomatic recurrences of AF refractory to antiarrhythmics will undergo ablation.
It will be analyzed that proportion of patients initially candidates for ablation cease to fulfill conditions for this by a better control of recurrences and "leave the waiting list". Likewise, the results of the ablation of the cohort of patients diagnosed with SAHS and the moderate or high-risk cohort of SAHS, but with negative polygraphy and diagnosis, will be compared.
The arrhythmic load after AF ablation will be analysed, during the blinding period (3 months post-ablation) and one year after the ablation. Patients will continue their SAHS treatment according to the usual practice of the Pneumology Service.
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Apnea Syndrome, Hypopnea Syndrome
- Being tested
- Treatment of SAHS
- Keywords
- Atrial Fibrillation, Apnea, Hypopnea, SAHS
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of SAHSOther
Patients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Patients with negative diagnosis of SAHS | No intervention | Patients with low risk or negative diagnosis of SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit |
| Patients with positive diagnosis of SAHS | Other | Patients with intermediate or high risk of SAHS and positive diagnosis Receives: Other: Treatment of SAHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmic load
Rate of time in FA measured with Kardia © recorder
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start5 Nov 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicasio Perez Castellano, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606693
- Sponsor's protocol ID
- 20/023-E
- Acronym
- SLEEP-AF
- Status last verified
- Sep 2025
- First submitted
- 16 Jan 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates
- ClinicalTrials.gov ID
- NCT04606693
- Acronym / sponsor ID
- SLEEP-AF / 20/023-E
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Apnea Syndrome, Hypopnea Syndrome
- Keywords
- Atrial Fibrillation, Apnea, Hypopnea, SAHS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 2020 (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.
The present prospective cohort study (not randomized) analyses the value of screening and treatment of SAHS in the management of patients with AF refractory to antiarrhythmics drugs, potentially candidates for ablation.
Patients at low risk of suffering from SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit. Patients with high or intermediate risk of SAHS, will undergo respiratory polygraphy. If the result is positive, they will be treated as standard for this syndrome and their heart rate will be monitored for 3 months. After this, the patient's arrhythmic load will be reevaluated differentiating patients into two groups, those that must be ablated from those that have improved their condition and the clinical criteria is no longer ablation but follow-up.
Detailed description
All patients who meet all the inclusion criteria and none of the exclusion will have a Stop-Bang questionnaire to define the risk of having a SAHS The assessment of results classifies people at high, intermediate or low risk of SAHS. Low-risk patients will follow conventional management according to the usual criteria of the Arrhythmia Unit.
Patients with high or intermediate-risk will be given a Kardia© recorder and they will be instructed to obtain records of their cardiac rhythm every 5 days (at any time) and whenever the symptoms are suggestived of arrhythmia. This allows estimating arrhythmic load baseline in these patients.
They will also will be given a 7-channel home respiratory polygraphy (with pulse oximetry record, naso-buccal air flow through nasal cannula and thermistor, snoring, thoracoabdominal movements and electrocardiogram). The day after conducting the home polygraphic record, the patient will be evaluated in the Pneumology Outpatient Department, where risk factors, symptoms and Epworth's sleepiness scale will be assessed, the results of the cardiorespiratory polygraphic record, interpreted by Pneumology Service will be given , and based on the above, the diagnosis of SAHS will be determined.
Those patients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.).
During all this time, patients will continue using their rhythm recorders as previously. The overall effect of SAHS treatment on AF recurrences (comparison of arrhythmic load in the previous 3 months with that of the 3 months post-treatment) will be evaluated.
After 3 months of starting the treatment, a follow-up respiratory polygraphy will be carried out, where the relationship between the changes in AHI and desaturation index as well as changes in arrhythmic load will be evaluated.
Once the follow-up respiratory polygraphy is performed, the indication of AF ablation will be reassessed. Patients who continue with symptomatic recurrences of AF refractory to antiarrhythmics will undergo ablation.
It will be analyzed that proportion of patients initially candidates for ablation cease to fulfill conditions for this by a better control of recurrences and "leave the waiting list". Likewise, the results of the ablation of the cohort of patients diagnosed with SAHS and the moderate or high-risk cohort of SAHS, but with negative polygraphy and diagnosis, will be compared.
The arrhythmic load after AF ablation will be analysed, during the blinding period (3 months post-ablation) and one year after the ablation. Patients will continue their SAHS treatment according to the usual practice of the Pneumology Service.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with negative diagnosis of SAHS | No intervention | –Patients with low risk or negative diagnosis of SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit |
| Patients with positive diagnosis of SAHS | Other | Other: Treatment of SAHSPatients with intermediate or high risk of SAHS and positive diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with paroxysmal or persistent atrial fibrillation
- Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic
- No previous diagnosis of apnea-hypopnea syndrome
Key exclusion criteria (5 listed)
- Patients <18 years
- Pregnant women
- Doubts about the patient's ability to perform a home respiratory polygraphy
- Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required)
- Unavailability for follow-up at our center for at least 1 year.
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 |
|---|---|---|
| Treatment of SAHSPatients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.). | Other | Patients with positive diagnosis of SAHS |
Primary outcome
Arrhythmic load
Time frame: Six months
Rate of time in FA measured with Kardia © recorder
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 15 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of SAHS in people with Atrial Fibrillation Paroxysmal and Atrial Fibrillation, Persistent, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. 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 Spain. 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?
Contact Nicasio Pérez-Castellano, MD PhD (+34913303000 ext. 7278, nicasio.perez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmic load (time frame: Six 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 15 Sep 2025.