Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates (SLEEP-AF)
Primary Purpose
Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Apnea Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Treatment of SAHS
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation Paroxysmal focused on measuring Atrial Fibrillation, Apnea, Hypopnea, SAHS
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital Clínico San CarlosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Patients with negative diagnosis of SAHS
Patients with positive diagnosis of SAHS
Arm Description
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 intermediate or high risk of SAHS and positive diagnosis
Outcomes
Primary Outcome Measures
Arrhythmic load
Rate of time in FA measured with Kardia © recorder
Secondary Outcome Measures
Full Information
NCT ID
NCT04606693
First Posted
January 16, 2020
Last Updated
January 24, 2022
Sponsor
Hospital San Carlos, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04606693
Brief Title
Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates
Acronym
SLEEP-AF
Official Title
Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Apnea Syndrome, Hypopnea Syndrome
Keywords
Atrial Fibrillation, Apnea, Hypopnea, SAHS
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with negative diagnosis of SAHS
Arm Type
No Intervention
Arm Description
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
Arm Title
Patients with positive diagnosis of SAHS
Arm Type
Other
Arm Description
Patients with intermediate or high risk of SAHS and positive diagnosis
Intervention Type
Other
Intervention Name(s)
Treatment of SAHS
Intervention Description
Patients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.).
Primary Outcome Measure Information:
Title
Arrhythmic load
Description
Rate of time in FA measured with Kardia © recorder
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicasio Pérez-Castellano, MD PhD
Phone
+34913303000
Ext
7278
Email
nicasio.perez@salud.madrid.org
Facility Information:
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicasio Pérez-Castellano, MDhPhD
Phone
+34913303000
Ext
7278
Email
dr.npc.clinical.trials@gmail.com
First Name & Middle Initial & Last Name & Degree
Norberto Torres-Esquivel, MD
First Name & Middle Initial & Last Name & Degree
María-Jesús García-Torrent, PhD
12. IPD Sharing Statement
Learn more about this trial
Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates
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