Obstructive Sleep ApneaNCT05814796
Assessment of Obstructive Sleep Apnea Syndrome in Non-Obese Patients
An observational study of Obstructive Sleep Apnea, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to Dec 2025
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: all patients addmitted to Chest Department, Assuit University Hospitals
Who may be able to join
- Patients above 18 yrs. old. 2.Informed consent to participate in the study is provided.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 .
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | BMI>30 | |
| Non obese | Overweight: BMI = 25-29.9 Normal weight: BMI = 18.5-24.9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate OSAS in non-obese patients, and to compare patient characteristics, clinical markers between obese and non-obese patients.
Weight in kilograms and height in meters weight and height will be combined to report BMI in kg/m^2).
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Sep 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assiut 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 crossover
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Atef Mohammed MohammedElgalaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814796
- Sponsor's protocol ID
- sleep apnea in non obese
- Status last verified
- Apr 2023
- First submitted
- 18 Jan 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Obstructive Sleep Apnea Syndrome in Non-Obese Patients
- ClinicalTrials.gov ID
- NCT05814796
- Acronym / sponsor ID
- sleep apnea in non obese
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Apr 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.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | –BMI>30 |
| Non obese | – | –Overweight: BMI = 25-29.9 Normal weight: BMI = 18.5-24.9 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients addmitted to Chest Department, Assuit University Hospitals
Key inclusion criteria (1 listed)
- Patients above 18 yrs. old. 2.Informed consent to participate in the study is provided.
Key exclusion criteria (7 listed)
- Neuromuscular disorders
- Psychiatric instability
- Suspected narcolepsy
- Uncontrolled cardiovascular disease (uncontrolled hypertension, heart failure, uncontrolled arrhythmia)
- Cheynes-Stokes syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Assiut University.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alaa atef (01060448697, elgalalyalaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate OSAS in non-obese patients, and to compare patient characteristics, clinical markers between obese and non-obese patients. (time frame: basline). 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 18 Apr 2023.