Atrial FibrillationNCT05990010
OSA Prevalence in Atrial Fibrillation Patients: Jordanian Study
An observational study of Atrial Fibrillation and Obstructive Sleep Apnea, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Current Knowledge: Countless studies have been conducted to study the relationship between OSA and AF, and a significant association has been established between both diseases, owing to the numerous shared risk factors and a wide variety of pathophysiological changes resulting from both diseases being relevant to each… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Obstructive Sleep Apnea
- What is being tested?
- Berlin Questionnaire
- How many people
- 545 participants
- Where
- 1 siteJordan
- Study dates
- 2 Feb 2020to 25 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who had visited King Abdullah University Hospital cardiology clinics within the timeframe of (2017-2019).
Who may be able to join
- Age 21 or above
Who cannot join
- Unable to give research consent
- Patients who were unwilling to complete the questionnaires
- Patients who suffer from mental illness
Trial locations and contacts
1 site in 1 country.
Jordan1 site
King Abdullah University Hospital cardiology clinics
Irbid, Ramtha, 22110
About this study
Official title: Prevalence of Obstructive Sleep Apnea Among Atrial Fibrillation Patients: A Cross-sectional Study From Jordan
Current Knowledge:
Countless studies have been conducted to study the relationship between OSA and AF, and a significant association has been established between both diseases, owing to the numerous shared risk factors and a wide variety of pathophysiological changes resulting from both diseases being relevant to each other. Our study inspects this relationship from a cardiovascular standpoint, examining the prevalence of OSA in existing AF patients, which could be interpreted as AF being a risk factor for OSA development.
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Being tested
- Berlin Questionnaire
- Keywords
- AF, OSA, berlin questionnaire
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berlin QuestionnaireDiagnostic test
The Berlin Questionnaire is a simple survey that helps doctors identify OSA risk. It looks at snoring, daytime sleepiness, obesity, and hypertension. A positive score in two or more areas indicates high risk, while one or none suggests low risk. It is an easy and effective tool to assess OSA risk, with proven validity.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AF | Not described Receives: Diagnostic Test: Berlin Questionnaire | |
| Patients without AF | Not described Receives: Diagnostic Test: Berlin Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Berlin Questionnaire survey
Prevalence of Obstructive Sleep Apnea among Atrial Fibrillation Patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Feb 2020
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rashid Ibdah, King Abdullah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990010
- Sponsor's protocol ID
- 22/130/2020
- Status last verified
- Oct 2023
- First submitted
- 5 Aug 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstructive Sleep Apnea Among Atrial Fibrillation Patients: A Cross-sectional Study From Jordan
- ClinicalTrials.gov ID
- NCT05990010
- Acronym / sponsor ID
- 22/130/2020
- Conditions
- Atrial Fibrillation, Obstructive Sleep Apnea
- Keywords
- AF, OSA, berlin questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 14 Aug 2023 (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.
Current Knowledge:
Countless studies have been conducted to study the relationship between OSA and AF, and a significant association has been established between both diseases, owing to the numerous shared risk factors and a wide variety of pathophysiological changes resulting from both diseases being relevant to each other. Our study inspects this relationship from a cardiovascular standpoint, examining the prevalence of OSA in existing AF patients, which could be interpreted as AF being a risk factor for OSA development.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with AF | – | Diagnostic Test: Berlin Questionnaire |
| Patients without AF | – | Diagnostic Test: Berlin Questionnaire |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had visited King Abdullah University Hospital cardiology clinics within the timeframe of (2017-2019).
Key inclusion criteria (1 listed)
- Age 21 or above
Key exclusion criteria (3 listed)
- Unable to give research consent
- Patients who were unwilling to complete the questionnaires
- Patients who suffer from mental illness
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 |
|---|---|---|
| Berlin QuestionnaireThe Berlin Questionnaire is a simple survey that helps doctors identify OSA risk. It looks at snoring, daytime sleepiness, obesity, and hypertension. A positive score in two or more areas indicates high risk, while one or none suggests low risk. It is an easy and effective tool to assess OSA risk, with proven validity. | Diagnostic test | Patients with AF, Patients without AF |
Primary outcome
The Berlin Questionnaire survey
Time frame: baseline
Prevalence of Obstructive Sleep Apnea among Atrial Fibrillation Patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation and Obstructive Sleep Apnea, run by King Abdullah University Hospital at 1 site in Jordan.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 Oct 2023. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Berlin Questionnaire survey (time frame: baseline). 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 4 Oct 2023.