OSANCT07370376
Ultrasonographic of Diaphragmatic Function in Obstructive Sleep Apnea
An observational study of OSA, run by Mansoura University at 1 site in Egypt.
Trial summary
Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Mar 2024
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients visiting the Sleep Disordered Breathing (SDB) Unit at the Chest Medicine Department and diagnosed with obstructive sleep apnea (OSA) were included if they met the following criteria: Age 18-65 years.; OSA group: Newly diagnosed OSA confirmed by full-night polysomnography (PSG) with apnea-hypopnea index (AHI) > 5 events/hour; Control group: Patients with AHI < 5 events/hour on PSG; Willingness to participate in the study.
Who may be able to join
- Patients visiting the Sleep Disordered Breathing (SDB) Unit at the Chest Medicine Department and diagnosed with obstructive sleep apnea (OSA) were included if they met the following criteria:
- Age 18-65 years.
- Willingness to participate in the study.
Who cannot join
- Patients were excluded if they had any of the following conditions:
- Refusal to participate in the study
- Age <18 or >65 years
- Systemic organ failure, including heart failure, stroke, renal failure, or liver failure; Uncontrolled diabetes mellitus
- Diagnosed obesity hypoventilation syndrome (OHS) or other sleep disorders apart from OSA
- Chronic respiratory diseases such as COPD, bronchial asthma, or restrictive lung disease
Show all 9Show fewer
- OSA patients already receiving therapy (CPAP, oral appliances, or upper airway surgery)
- Neuromuscular disorders or other conditions affecting diaphragmatic function (malnutrition, chest trauma, or immobility)
- Use of steroids or uncontrolled autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients
Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity.
Read the detailed description
Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity. The aim of the study is to evaluate diaphragmatic function in OSA patients using ultrasonography and to investigate its relationship with OSA severity and sleep-related parameters.
- Conditions
- OSA
- Keywords
- Ultrasonographic Assessment, Diaphragmatic Function, 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 |
|---|---|---|
| newly diagnosed OSA patients (AHI ≥5) | 30 newly diagnosed OSA patients (AHI ≥5). All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF). | |
| non-OSA controls (AHI <5) | All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients
All participants underwent diaphragm thickening fraction (DTF) as a percentage (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Mansoura 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MohamedAbdElmoniem, Mansoura University
- Investigators
- Mohamed AbdElmoniem, Principal investigator, Lecturer of chest medicine faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370376
- Sponsor's protocol ID
- MS.23.03.2352
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT07370376
- Acronym / sponsor ID
- MS.23.03.2352
- Conditions
- OSA
- Keywords
- Ultrasonographic Assessment, Diaphragmatic Function, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 27 Jan 2026 (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.
Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity.
Detailed description
Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity. The aim of the study is to evaluate diaphragmatic function in OSA patients using ultrasonography and to investigate its relationship with OSA severity and sleep-related parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed OSA patients (AHI ≥5) | – | –30 newly diagnosed OSA patients (AHI ≥5). All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF). |
| non-OSA controls (AHI <5) | – | –All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the Sleep Disordered Breathing (SDB) Unit at the Chest Medicine Department and diagnosed with obstructive sleep apnea (OSA) were included if they met the following criteria: Age 18-65 years.; OSA group: Newly diagnosed OSA confirmed by full-night polysomnography (PSG) with apnea-hypopnea index (AHI) > 5 events/hour; Control group: Patients with AHI < 5 events/hour on PSG; Willingness to participate in the study.
Key inclusion criteria (3 listed)
- Patients visiting the Sleep Disordered Breathing (SDB) Unit at the Chest Medicine Department and diagnosed with obstructive sleep apnea (OSA) were included if they met the following criteria:
- Age 18-65 years.
- Willingness to participate in the study.
Key exclusion criteria (9 listed)
- Patients were excluded if they had any of the following conditions:
- Refusal to participate in the study
- Age <18 or >65 years
- Systemic organ failure, including heart failure, stroke, renal failure, or liver failure; Uncontrolled diabetes mellitus
- Diagnosed obesity hypoventilation syndrome (OHS) or other sleep disorders apart from OSA
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
Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients
Time frame: 6 months
All participants underwent diaphragm thickening fraction (DTF) as a percentage (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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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.
Mohamed AbdElmoniem principal investigator
Lecturer of chest medicine faculty of medicine Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients (time frame: 6 months). 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 27 Jan 2026.