Back to resultsBASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome (OSAS) Patients (BASET)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BASET score
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- All adult patients after having full night polysomnography.
Exclusion Criteria:
- Pregnant patients
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
obstructive sleep apnea patients
Arm Description
Group I : consist of sixty-three patients having OSA. Group II : consist of sixty-three non-OSA patients.
Outcomes
Primary Outcome Measures
assess the performance of BASET score for diagnosis of OSAS
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).
grading of the severity of OSAS patients.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05511974
Brief Title
BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome (OSAS) Patients
Acronym
BASET
Official Title
BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
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
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
obstructive sleep apnea patients
Arm Type
Other
Arm Description
Group I : consist of sixty-three patients having OSA. Group II : consist of sixty-three non-OSA patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
BASET score
Intervention Description
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
Primary Outcome Measure Information:
Title
assess the performance of BASET score for diagnosis of OSAS
Description
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).
Time Frame
up to 2 weeks.
Title
grading of the severity of OSAS patients.
Description
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).
Time Frame
up to one week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adult patients after having full night polysomnography.
Exclusion Criteria:
Pregnant patients
Facility Information:
Facility Name
Mansoura University
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
BASET Scoring: A Novel Simple Biometric Score and Potential Tool for Diagnosis and Grading of Obstructive Sleep Apnea Syndrome (OSAS) Patients
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