BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome (OSAS) Patients (BASET)

August 22, 2022 updated by: Amira attia, Mansoura University

BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome Patients

this study aims to assess the validity of BASET scoring as a new potential tool for diagnosis and grading the severity of OSAS patients and as screening of the risk factors of OSAS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adult patients after having full night polysomnography.

Exclusion Criteria:

  • Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: obstructive sleep apnea patients
Group I : consist of sixty-three patients having OSA. Group II : consist of sixty-three non-OSA patients.
Diagnostic test: BASET score
The patients were divided into two groups. Group I (study group): consist of sixty-three patients having OSA. Group II (control group): consist of eighty-one non-OSA patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the performance of BASET score for diagnosis of OSAS
Time Frame: up to 2 weeks.
assess the performance of BASET score for diagnosis OSAS Region is neither concave nor dark red will take score (0). Region which is dark red but not concave will take score (1). Region which is concave but not dark red will take score (2). Region which is dark red and concave will take score (3).
up to 2 weeks.
grading of the severity of OSAS patients.
Time Frame: up to one week
grading of the severity of OSAS patients. Region is neither concave nor dark red will take score (0). Region which is dark red but not concave will take score (1). Region which is concave but not dark red will take score (2). Region which is dark red and concave will take score (3).
up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

July 5, 2022

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.22.06.1737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study will be conducted on one hundred twenty-six patients attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography. The patients will be divided into two groups:

Group I (study group): consist of sixty-three patients having OSA. Group II (control group): consist of sixty-three non-OSA patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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