Metabolic Syndrome and Obstructive Sleep Apnea

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06051097
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 8.4
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea; Metabolic Syndrome	Diagnostic Test: sleep study

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Relationship Between Metabolic Syndrome and Obstructive Sleep Apnea
• Actual Study Start Date: Sep 1, 2022
• Actual Primary Completion Date: Mar 31, 2023
• Actual Study Completion Date: May 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
OSA with metabolic syndrome sleep study	Diagnostic Test: sleep study; over-night polysomnography
OSA without metabolic syndrome sleep study	Diagnostic Test: sleep study; over-night polysomnography

Outcome Measures

Primary Outcome Measures

1. Predictors of metabolic syndrome among OSA patients [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 77 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Cerebro-vascular accident within the preceding 30 days.

2. Patients on sedatives.

3. Patients on anti-psychotics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr alainy school of medicine	Cairo		Egypt	11562

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman Kamal Ibrahim Hassan, Assistant Professor of pulmonology, Cairo University
• ClinicalTrials.gov Identifier: NCT06051097
• Other Study ID Numbers: MS-258-2022
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Sep 22, 2023