- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326580
Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals
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
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
- Patients aged >18 years old
- 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.
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.
- Sleep Study (PSG) Diagnostic polysomnogram that had been done for all the patients for diagnostic purpose will be assessed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dakhlia
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Mansoura, Dakhlia, Egypt, 050
- Mansoura University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged >18 years old
- 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
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS.22.09.2144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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