NCT05511974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 9, 2022

Last Update Submit

August 22, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    up to 2 weeks.

  • 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).

    up to one week

Study Arms (1)

obstructive sleep apnea patients

OTHER

Group I : consist of sixty-three patients having OSA. Group II : consist of sixty-three non-OSA patients.

Diagnostic Test: BASET score

Interventions

BASET scoreDIAGNOSTIC_TEST

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

obstructive sleep apnea patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients after having full night polysomnography.

You may not qualify if:

  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

  • Saleh AM, Ahmed MA, El Said EA, Awadalla NJ, Attia AAMM. BASET scoring: A novel simple biometric score for screening and grading obstructive sleep apnea. Sleep Med X. 2023 Aug 14;6:100083. doi: 10.1016/j.sleepx.2023.100083. eCollection 2023 Dec 15.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 23, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 5, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

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.

Locations