Osa SyndromeNCT06326580
Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals
An observational study of Osa Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osa Syndrome
- How many people
- 1,129 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 20 Feb 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Egyptian patients in sleep study unit, ChestDepartment Mansoura University Hospital, Egypt
Who may be able to join
- Patients aged >18 years old
- presented with symptoms suggestive of OSA like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Osa Syndrome
- Medical subject headings
- Carnevale syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start20 Oct 2022
- Primary completion20 Oct 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osa SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,129 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Awad, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326580
- Sponsor's protocol ID
- MS.22.09.2144
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals
- ClinicalTrials.gov ID
- NCT06326580
- Acronym / sponsor ID
- MS.22.09.2144
- Conditions
- Osa Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Egyptian patients in sleep study unit, ChestDepartment Mansoura University Hospital, Egypt
Key inclusion criteria (2 listed)
- Patients aged >18 years old
- presented with symptoms suggestive of OSA like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
Related trials for Osa Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osa Syndrome, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.