OSA Prevalence in Atrial Fibrillation Patients: Jordanian... | NCT05990010

Studies
OSA Prevalence in Atrial Fibrillation Patients: Jordanian Study

NCT05990010

Sponsor

King Abdullah University Hospital

Status

Completed

Last Update Posted

Oct 4, 2023Actual

Enrollment

545Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Obstructive Sleep Apnea

Interventions

Berlin Questionnaire

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2020Actual

Primary Completion Date

Jul 25, 2023Actual

Completion Date

Jul 25, 2023Actual

First Submitted Date

Aug 5, 2023

First Submission Date that Met QC Criteria

Aug 11, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2023

Last Update Posted Date

Oct 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rashid Ibdah, Rashid Ibdah, MD, King Abdullah University HospitalPrincipal Investigator

Lead Sponsor

King Abdullah University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

545Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with AF			Diagnostic Test: Berlin Questionnaire
Patients without AF			Diagnostic Test: Berlin Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Berlin Questionnaire	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Berlin Questionnaire survey	Prevalence of Obstructive Sleep Apnea among Atrial Fibrillation Patients	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 21 or above

Exclusion Criteria:

Unable to give research consent
Patients who were unwilling to complete the questionnaires
Patients who suffer from mental illness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who had visited King Abdullah University Hospital cardiology clinics within the timeframe of (2017-2019).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Abdullah University Hospital cardiology clinics		Irbid	Ramtha	22110	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided