- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051097
Metabolic Syndrome and Obstructive Sleep Apnea
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 11562
- Kasr Alainy School of Medicine
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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 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.
Exclusion Criteria:
- Cerebro-vascular accident within the preceding 30 days.
- Patients on sedatives.
- Patients on anti-psychotics
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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OSA with metabolic syndrome
sleep study
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over-night polysomnography
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OSA without metabolic syndrome
sleep study
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over-night polysomnography
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Predictors of metabolic syndrome among OSA patients
Time Frame: 6 months
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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)
|
6 months
|
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
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Signs and Symptoms, Respiratory
- Insulin Resistance
- Hyperinsulinism
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Syndrome
- Apnea
- Metabolic Syndrome
Other Study ID Numbers
- MS-258-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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