Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals

March 20, 2024 updated by: Tamer Awad, Mansoura University

Obstructive sleep apnea syndrome (OSAS)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (Kuczynski, W., 2019). These episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (Huon, L.-K.A., 2017). OSAS predominantly affects 26% of individuals between 30 and 70 years in the U.S (apnea hypopnea index ≥5 events per hour) (Schwartz, M., 2018).

Obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. Yet this disorder remains undiagnosed in a substantial portion of our population. It is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with OSA (Park, J. G., 2011).

The test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study

Study Overview

Status

Completed

Conditions

Detailed Description

Aim of study:

To identify standard clinical parameters that may predict the presence of obstructive sleep apnea (OSA) among Egyptian patients in sleep study unit, ChestDepartment Mansoura University Hospital, Egypt Study Design :Retrospective study The study will include the patients who visited sleep outpatient clinic of sleep disordered breathing unit of Chest Department, Mansoura University from 2004 to 2022 Inclusion criteria

  1. Patients aged >18 years old
  2. presented with symptoms suggestive of OSA like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea Exclusion criteria :Patients with long-term use of medications known to affect sleep integrity,Current alcohol or drug abuse, History of psychosis ,Central sleep apnea syndromes ,Previous OSA surgery ,Other sleep disorders

METHODS:

Study Design: this is retrospective study The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected.

  1. Physical examination:

    • All recorded vital data, height, weight, and body mass index (BMI) of the patients will be collected
    • The probability of OSA using the STOP-BANG and Berlinequestionnaire in all the patients will be collected
    • The calculated Epworth Sleepiness Scale (ESS) for each patient will be assessed.
  2. Sleep Study (PSG) Diagnostic polysomnogram that had been done for all the patients for diagnostic purpose will be assessed.

Study Type

Observational

Enrollment (Actual)

1129

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

    • Dakhlia
      • Mansoura, Dakhlia, Egypt, 050
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Egyptian patients in sleep study unit, ChestDepartment Mansoura University Hospital, Egypt

Description

Inclusion Criteria:

  1. Patients aged >18 years old
  2. presented with symptoms suggestive of OSA like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea

Exclusion Criteria:

  1. Patients with long-term use of medications known to affect sleep integrity Current
  2. alcohol or drug abuse
  3. History of psychosis
  4. Central sleep apnea syndromes
  5. Previous OSA surgery
  6. Other sleep disorders

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected.
Time Frame: 1 year
The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected.
1 year

Collaborators and Investigators

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

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)

October 20, 2022

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

February 20, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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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