Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05814796 |
| Other study ID # |
sleep apnea in non obese |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
April 2023 |
| Source |
Assiut University |
| Contact |
alaa atef |
| Phone |
01060448697 |
| Email |
elgalalyalaa[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to evaluate OSAS in non-obese patients, and to compare patient
characteristics, clinical markers between obese and non-obese patients.
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 .
