Clinical Trial on Obstructive Sleep Apnea - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Obstructive Sleep Apnea

Detailed Description

OSAS (obstructive sleep apnea syndrome) is characterized by repeated collapses of the upper airways that result in a marked reduction (hypopnea) or complete interruption (apnea) of the airflow. Polysomnography is the gold standard tool for diagnosis. OSAS is defined broadly as an apnea-hypopnea index (AHI) greater than five events per hour of sleep.

The events of apneas and hypopneas are followed by phasic oxyhemoglobin desaturations, with consequent intermittent hypoxemia, sympathetic hyperactivation, and sleep fragmentation. This results in many complications such as: atherosclerosis, acute coronary syndrome , diabetes , stroke , premature death , reduction of cognitive functions and quality of life .

OSA is the most common sleep-related breathing disorder (SRBD). The estimated prevalence in North America is approximately 15- 30 % in males and 10 - 15 % in females . Global estimates using five or more events per hour suggest rates of 936 million people worldwide with mild to severe OSAS, and 425 million people worldwide with moderate to severe OSAS, between the ages of 30 and 69 years of age . OSA has a racial predisposition. It is more prevalent in African Americans who are younger than 35 years old compared with White Americans of the same age group, independent of body weight . The prevalence of OSAS appears to be increasing and may be related to the increasing rates of obesity and increased detection rates of OSA .

It is well known that obesity is the main risk factor for OSAS . On the other hand, there are multiple risk factors than can occur in non-obese. These risk factors include anatomical factors e.g. retrognathia, soft palate laxity, craniofacial conformations of reduced dimensions and macroglossia, which lead to greater collapse of the upper airways in non-obese patients . In addition, genetic predisposition, smoking, alcohol consumption, and gender play a role as risk factors for OSAS. The different pathophysiological mechanisms results in different disease phenotypes .

Pathophysiology of OSAS is complex. This include: instability of ventilatory control, also known as high loop gain, neuromuscular inefficiency of the dilator muscles of the upper airways and reduced awakening threshold, also known as low arousal threshold The relation of obesity with OSAS is well-established, and has been thoroughly investigated. However, the proportion of patients with OSAS who are not obese, their clinical presentation, pathophysiological mechanisms and response to therapies has been minimally investigated .

Study Type

Observational

Enrollment (Anticipated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: alaa atef
Phone Number: 01060448697
Email: elgalalyalaa@gmail.com

Study Contact Backup

Name: Mohammed Gamal
Phone Number: +201026600071
Email: dr.mga2011@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

all patients addmitted to Chest Department, Assuit University Hospitals

Description

Inclusion Criteria:

Patients above 18 yrs. old. 2.Informed consent to participate in the study is provided.
Exclusion Criteria:
- 1. Pregnancy
Neuromuscular disorders
Psychiatric instability
Suspected narcolepsy
Uncontrolled cardiovascular disease (uncontrolled hypertension, heart failure, uncontrolled arrhythmia)
Cheynes-Stokes syndrome
Inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Obese patients BMI>30
Non obese Overweight: BMI = 25-29.9 Normal weight: BMI = 18.5-24.9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate OSAS in non-obese patients, and to compare patient characteristics, clinical markers between obese and non-obese patients. Time Frame: basline	Weight in kilograms and height in meters weight and height will be combined to report BMI in kg/m^2).	basline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)