Sleep ApneaNCT06051097
Metabolic Syndrome and Obstructive Sleep Apnea
An observational study of Sleep Apnea and Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Background:Metabolic syndrome is a disorder characterized by abdominal obesity,hypertension,increased triglycerides ,decreased HDL cholesterol and increased blood glucose. Accumulating evidence strongly indicates that insulin resistance and an increased amount of abdominal fat are the pathogenic factors for the… Read more about this study
- Who is it for?
- Ages 22 to 77 years
- Conditions the study is for
- Sleep Apnea, Metabolic Syndrome
- What is being tested?
- sleep study
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 15 May 2023
- 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 22 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was conducted in the pulmonology department at kasrelainy hospital.Itincluded 80 patients who came to the sleep lab unit for polysomnography.Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck \& hip circumference and blood pressure measurements,Laboratory investigations including: Lipid profile\&Diabetic profile(HBA1C).In addition to ESS and stop-bang score questionnaire
Who may be able to join
- Patients fulfilled the criteria of OSA ( obstructive sleep apnea) in the form of symptoms suggestive of OSA (daytime sleepiness/daytime fatigue/headache/snoring)and with AHI ( apnea-hyponea index) ≥5.
Who cannot join
- Cerebro-vascular accident within the preceding 30 days.
- Patients on sedatives.
- Patients on anti-psychotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Metabolic Syndrome and Obstructive Sleep Apnea
Background:Metabolic syndrome is a disorder characterized by abdominal obesity,hypertension,increased triglycerides ,decreased HDL cholesterol and increased blood glucose. Accumulating evidence strongly indicates that insulin resistance and an increased amount of abdominal fat are the pathogenic factors for the characteristics of metabolic syndrome. Studies indicate that sleep apnea may be a manifestation of the metabolic syndrome.
Subjects and methods:This study was conducted in the pulmonology department at kasrelainy hospital. It included 80 patients who came to the sleep lab unit for polysomnography. Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck\&hip circumference and blood pressure measurements,Laboratory investigations including :Lipid profile\& Diabetic profile(HBA1C).In addition to ESS and stop bang score questionnaire.
- Conditions
- Sleep Apnea, Metabolic Syndrome
- Being tested
- sleep study
- Medical subject headings
- Sleep Apnea Syndromes, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep studyDiagnostic test
over-night polysomnography
| Study group | Role | What they receive |
|---|---|---|
| OSA with metabolic syndrome | sleep study Receives: Diagnostic Test: sleep study | |
| OSA without metabolic syndrome | sleep study Receives: Diagnostic Test: sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of metabolic syndrome among OSA patients
evaluation of factors related to occurrence of metabolic syndrome in OSA such as age(in years),weight in kilograms(kg) and height in meters (m) will not be measured separately but combined to assess BMI( weight in kg/ height in m2) and oxygen saturation (O2%), evaluation of polysomnographic data and laboratory tests in the form of lipid profile in (mg/dl) and HBA1C (g/dl)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Sep 2022
- Primary completion31 Mar 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kamal Ibrahim Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051097
- Sponsor's protocol ID
- MS-258-2022
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Metabolic Syndrome and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06051097
- Acronym / sponsor ID
- MS-258-2022
- Conditions
- Sleep Apnea, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 22 Sep 2023 (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.
Background:Metabolic syndrome is a disorder characterized by abdominal obesity,hypertension,increased triglycerides ,decreased HDL cholesterol and increased blood glucose. Accumulating evidence strongly indicates that insulin resistance and an increased amount of abdominal fat are the pathogenic factors for the characteristics of metabolic syndrome. Studies indicate that sleep apnea may be a manifestation of the metabolic syndrome.
Subjects and methods:This study was conducted in the pulmonology department at kasrelainy hospital. It included 80 patients who came to the sleep lab unit for polysomnography. Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck\&hip circumference and blood pressure measurements,Laboratory investigations including :Lipid profile\& Diabetic profile(HBA1C).In addition to ESS and stop bang score questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA with metabolic syndrome | – | Diagnostic Test: sleep studysleep study |
| OSA without metabolic syndrome | – | Diagnostic Test: sleep studysleep study |
Who may qualify
- Ages
- 22 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted in the pulmonology department at kasrelainy hospital.Itincluded 80 patients who came to the sleep lab unit for polysomnography.Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck \& hip circumference and blood pressure measurements,Laboratory investigations including: Lipid profile\&Diabetic profile(HBA1C).In addition to ESS and stop-bang score questionnaire
Key inclusion criteria (1 listed)
- Patients fulfilled the criteria of OSA ( obstructive sleep apnea) in the form of symptoms suggestive of OSA (daytime sleepiness/daytime fatigue/headache/snoring)and with AHI ( apnea-hyponea index) ≥5.
Key exclusion criteria (3 listed)
- Cerebro-vascular accident within the preceding 30 days.
- Patients on sedatives.
- Patients on anti-psychotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep studyover-night polysomnography | Diagnostic test | OSA with metabolic syndrome, OSA without metabolic syndrome |
Primary outcome
Predictors of metabolic syndrome among OSA patients
Time frame: 6 months
evaluation of factors related to occurrence of metabolic syndrome in OSA such as age(in years),weight in kilograms(kg) and height in meters (m) will not be measured separately but combined to assess BMI( weight in kg/ height in m2) and oxygen saturation (O2%), evaluation of polysomnographic data and laboratory tests in the form of lipid profile in (mg/dl) and HBA1C (g/dl)
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 Sep 2023.
- Individual participant dataSharing planned: No
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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 Sleep Apnea and Metabolic Syndrome, run by Cairo 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 1 inclusion and 3 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 Sep 2023. 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?
Predictors of metabolic syndrome among OSA patients (time frame: 6 months). 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 Sep 2023.