Obstructive Sleep Apnea of ChildNCT07380321
Diaphragm Ultrasound İn Children With OSAS
An observational study of Obstructive Sleep Apnea of Child, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This is a prospective observational study evaluating perioperative diaphragmatic function by ultrasonography in children aged 1-12 years undergoing elective surgery under general anesthesia. Participants will be classified preoperatively based on the parent-completed Pediatric Sleep Questionnaire (PSQ). Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Child
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 1-12 years who are followed at the Department of Otolaryngology of Istanbul University Istanbul Faculty of Medicine and are scheduled for surgery will be included in this study. Participants will be assessed preoperatively using the Pediatric Sleep Questionnaire (PSQ). Children who answer "yes" to at least 8 of the 22 items and are scheduled to undergo adenotonsillectomy will be assigned to the obstructive sleep apnea syndrome (OSAS) group, whereas children who answer "yes" to fewer than 8 items and are scheduled to undergo elective non-airway-related otolaryngologic surgery will be included in the control group. Only children with ASA physical status I-II who meet the inclusion and exclusion criteria and for whom informed consent has been obtained will be enrolled.
Who may be able to join
- ASA physical status I-II
- Children aged 1 to 12 years
- Scheduled to undergo elective surgery under general anesthesia
- Written informed consent obtained from parents or legal guardians
- Availability of a completed pediatric sleep questionnaire (PSQ)
Who cannot join
- Patients younger than 1 year or older than 12 years
- Presence of a neuromuscular disease
- Use of medications that may affect neuromuscular function
- Diaphragmatic paralysis
- ASA physical status III-IV
- Refusal to participate in the study or failure to provide informed consent
- Body mass index (BMI) > 35 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Department of Anesthesiology
Istanbul, Fatih, 34093
Furkan Kelebek, Resident, +905426140993, furkan.kelebek@istanbul.edu.tr
Demet Altun, Professor
About this study
Official title: Perioperative Ultrasonographic Assessment Of Diaphragmatic Function İn Pediatric Obstructive Sleep Apnea
This is a prospective observational study evaluating perioperative diaphragmatic function by ultrasonography in children aged 1-12 years undergoing elective surgery under general anesthesia.
Participants will be classified preoperatively based on the parent-completed Pediatric Sleep Questionnaire (PSQ). Children with suspected obstructive sleep apnea syndrome who are scheduled for adenotonsillectomy will form the study group, while children without clinical findings suggestive of obstructive sleep apnea who are scheduled for elective non-airway-related otolaryngologic surgeries will serve as controls.
Read more
Diaphragm ultrasound assessments will be performed before and after surgery in the supine position during spontaneous breathing. Measurements will include diaphragmatic thickness at end-inspiration and end-expiration, diaphragmatic thickening fraction, and diaphragmatic excursion during quiet and deep breathing.
The primary objective is to compare diaphragmatic excursion and thickening fraction between groups. Secondary objectives include evaluating the association between perioperative respiratory parameters, postoperative recovery, and diaphragm ultrasound measures.
Read the detailed description
This prospective observational study is designed to evaluate perioperative diaphragmatic function using ultrasonography in pediatric patients undergoing elective surgery under general anesthesia. The study will be conducted in children aged 1-12 years who are followed at the Department of Otolaryngology of Istanbul University Istanbul Faculty of Medicine and are scheduled for surgery based on clinical indications.
A total of 60 children will be enrolled in the study in accordance with predefined inclusion and exclusion criteria. Participants will be classified into two groups based on the results of the parent-completed Pediatric Sleep Questionnaire (PSQ) administered preoperatively. A PSQ total score of ≥0.33 (at least 8 "yes" responses out of 22 items) will be considered indicative of suspected obstructive sleep apnea, and children scheduled for adenotonsillectomy will form the study group. Children with a PSQ total score of <0.33 and no clinical findings suggestive of obstructive sleep apnea who are scheduled for elective non-airway-related otolaryngologic surgeries will be included in the control group.
All patients will receive standardized perioperative anesthesia and surgical care. Diaphragmatic ultrasonographic assessments will be performed in the supine position during spontaneous breathing preoperatively and postoperatively. Diaphragmatic thickness will be assessed using a 4-15 MHz linear transducer placed perpendicular to the chest wall at the 7th-9th intercostal space along the right anterior axillary line; thickness will be measured at end-inspiration and end-expiration, and the diaphragmatic thickening fraction will be calculated. Diaphragmatic excursion will be evaluated using a 1-6 MHz convex transducer positioned in the right anterior subcostal region between the midclavicular and anterior axillary lines, and craniocaudal excursion will be recorded during quiet and deep breathing.
The primary objective of this study is to evaluate diaphragmatic function by comparing diaphragmatic thickening fraction between children with suspected obstructive sleep apnea and a control group. Secondary objectives include the assessment of diaphragmatic excursion, the evaluation of associations between diaphragmatic ultrasonography parameters and perioperative respiratory variables, and the assessment of postoperative recovery characteristics. In this context, the study aims to investigate the role of diaphragmatic ultrasonography as a noninvasive perioperative assessment tool for the evaluation of respiratory function and perioperative respiratory findings in children with suspected obstructive sleep apnea undergoing surgery.
- Conditions
- Obstructive Sleep Apnea of Child
- Keywords
- Pediatric Sleep Questionnaire, diaphragm ultrasound, adenotonsillectomy
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 |
|---|---|---|
| Obstructive Sleep Apnea Group | Children with obstructive sleep apnea syndrome, defined by at least 8 "yes" responses out of 22 items on the Pediatric Sleep Questionnaire (PSQ), scheduled for adenotonsillectomy under general anesthesia. | |
| Control Group | Children without obstructive sleep apnea, defined by fewer than 8 "yes" responses out of 22 items on the Pediatric Sleep Questionnaire (PSQ), scheduled for elective non-airway-related otolaryngologic surgeries under general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic Thickening Fraction (%)
Diaphragmatic thickening fraction will be calculated as (thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration × 100%, measured by ultrasound. The primary comparison will be between the OSAS group and the control group. Measurements will be assessed before and after surgery.
Measured: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Secondary outcomes (6)
Diaphragmatic Thickness at End-Inspiration (mm)
Diaphragmatic thickness at end-inspiration will be measured by ultrasonography. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements.
Measured: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Perioperative Respiratory and Recovery Parameters
Perioperative respiratory and recovery parameters will be recorded, including oxygen saturation (SpO₂), end-tidal carbon dioxide (EtCO₂) values, Aldrete scores at recovery room admission and discharge, and length of stay in the recovery room. These parameters will be evaluated for associations with diaphragmatic ultrasonography measures and study group (OSAS vs control).
Measured: During surgery and for the duration of postoperative recovery.
Diaphragmatic Thickness at End-Expiration (mm)
Diaphragmatic thickness at end-expiration will be measured by ultrasonography. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements
Measured: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Diaphragmatic Excursion During Quiet Breathing (mm)
Craniocaudal diaphragmatic excursion during quiet tidal breathing will be measured by M-mode ultrasonography. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements.
Measured: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Diaphragmatic Excursion During Deep Breathing (mm)
Craniocaudal diaphragmatic excursion during deep breathing will be measured by M-mode ultrasonography. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements.
Measured: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Diaphragmatic Excursion Ratio (Quiet Breathing / Deep Breathing)
The ratio of diaphragmatic excursion during quiet breathing to diaphragmatic excursion during deep breathing will be calculated. Values will be compared between the OSAS group and the control group, as well as between preoperative and postoperative measurements.
Measured: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Sep 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of ChildStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Altun, Istanbul University
- Investigators
- Furkan Kelebek, Resident, Principal investigator, Istanbul UniversityDemet Altun, Professor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380321
- Sponsor's protocol ID
- 2024/2005
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 2 Feb 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Ultrasonographic Assessment Of Diaphragmatic Function İn Pediatric Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07380321
- Acronym / sponsor ID
- 2024/2005
- Conditions
- Obstructive Sleep Apnea of Child
- Keywords
- Pediatric Sleep Questionnaire, diaphragm ultrasound, adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 2 Feb 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.
This is a prospective observational study evaluating perioperative diaphragmatic function by ultrasonography in children aged 1-12 years undergoing elective surgery under general anesthesia.
Participants will be classified preoperatively based on the parent-completed Pediatric Sleep Questionnaire (PSQ). Children with suspected obstructive sleep apnea syndrome who are scheduled for adenotonsillectomy will form the study group, while children without clinical findings suggestive of obstructive sleep apnea who are scheduled for elective non-airway-related otolaryngologic surgeries will serve as controls.
Diaphragm ultrasound assessments will be performed before and after surgery in the supine position during spontaneous breathing. Measurements will include diaphragmatic thickness at end-inspiration and end-expiration, diaphragmatic thickening fraction, and diaphragmatic excursion during quiet and deep breathing.
The primary objective is to compare diaphragmatic excursion and thickening fraction between groups. Secondary objectives include evaluating the association between perioperative respiratory parameters, postoperative recovery, and diaphragm ultrasound measures.
Detailed description
This prospective observational study is designed to evaluate perioperative diaphragmatic function using ultrasonography in pediatric patients undergoing elective surgery under general anesthesia. The study will be conducted in children aged 1-12 years who are followed at the Department of Otolaryngology of Istanbul University Istanbul Faculty of Medicine and are scheduled for surgery based on clinical indications.
A total of 60 children will be enrolled in the study in accordance with predefined inclusion and exclusion criteria. Participants will be classified into two groups based on the results of the parent-completed Pediatric Sleep Questionnaire (PSQ) administered preoperatively. A PSQ total score of ≥0.33 (at least 8 "yes" responses out of 22 items) will be considered indicative of suspected obstructive sleep apnea, and children scheduled for adenotonsillectomy will form the study group. Children with a PSQ total score of <0.33 and no clinical findings suggestive of obstructive sleep apnea who are scheduled for elective non-airway-related otolaryngologic surgeries will be included in the control group.
All patients will receive standardized perioperative anesthesia and surgical care. Diaphragmatic ultrasonographic assessments will be performed in the supine position during spontaneous breathing preoperatively and postoperatively. Diaphragmatic thickness will be assessed using a 4-15 MHz linear transducer placed perpendicular to the chest wall at the 7th-9th intercostal space along the right anterior axillary line; thickness will be measured at end-inspiration and end-expiration, and the diaphragmatic thickening fraction will be calculated. Diaphragmatic excursion will be evaluated using a 1-6 MHz convex transducer positioned in the right anterior subcostal region between the midclavicular and anterior axillary lines, and craniocaudal excursion will be recorded during quiet and deep breathing.
The primary objective of this study is to evaluate diaphragmatic function by comparing diaphragmatic thickening fraction between children with suspected obstructive sleep apnea and a control group. Secondary objectives include the assessment of diaphragmatic excursion, the evaluation of associations between diaphragmatic ultrasonography parameters and perioperative respiratory variables, and the assessment of postoperative recovery characteristics. In this context, the study aims to investigate the role of diaphragmatic ultrasonography as a noninvasive perioperative assessment tool for the evaluation of respiratory function and perioperative respiratory findings in children with suspected obstructive sleep apnea undergoing surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea Group | – | –Children with obstructive sleep apnea syndrome, defined by at least 8 "yes" responses out of 22 items on the Pediatric Sleep Questionnaire (PSQ), scheduled for adenotonsillectomy under general anesthesia. |
| Control Group | – | –Children without obstructive sleep apnea, defined by fewer than 8 "yes" responses out of 22 items on the Pediatric Sleep Questionnaire (PSQ), scheduled for elective non-airway-related otolaryngologic surgeries under general anesthesia. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 1-12 years who are followed at the Department of Otolaryngology of Istanbul University Istanbul Faculty of Medicine and are scheduled for surgery will be included in this study. Participants will be assessed preoperatively using the Pediatric Sleep Questionnaire (PSQ). Children who answer "yes" to at least 8 of the 22 items and are scheduled to undergo adenotonsillectomy will be assigned to the obstructive sleep apnea syndrome (OSAS) group, whereas children who answer "yes" to fewer than 8 items and are scheduled to undergo elective non-airway-related otolaryngologic surgery will be included in the control group. Only children with ASA physical status I-II who meet the inclusion and exclusion criteria and for whom informed consent has been obtained will be enrolled.
Key inclusion criteria (5 listed)
- ASA physical status I-II
- Children aged 1 to 12 years
- Scheduled to undergo elective surgery under general anesthesia
- Written informed consent obtained from parents or legal guardians
- Availability of a completed pediatric sleep questionnaire (PSQ)
Key exclusion criteria (7 listed)
- Patients younger than 1 year or older than 12 years
- Presence of a neuromuscular disease
- Use of medications that may affect neuromuscular function
- Diaphragmatic paralysis
- ASA physical status III-IV
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
Diaphragmatic Thickening Fraction (%)
Time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Diaphragmatic thickening fraction will be calculated as (thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration × 100%, measured by ultrasound. The primary comparison will be between the OSAS group and the control group. Measurements will be assessed before and after surgery.
6 secondary outcomes
Diaphragmatic Thickness at End-Inspiration (mm)
Time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Perioperative Respiratory and Recovery Parameters
Time frame: During surgery and for the duration of postoperative recovery.
Diaphragmatic Thickness at End-Expiration (mm)
Time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Diaphragmatic Excursion During Quiet Breathing (mm)
Time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Diaphragmatic Excursion During Deep Breathing (mm)
Time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Diaphragmatic Excursion Ratio (Quiet Breathing / Deep Breathing)
Time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
Furkan Kelebek, Resident principal investigator
Istanbul University
Demet Altun, Professor principal investigator
Istanbul 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 Obstructive Sleep Apnea of Child, run by Istanbul University at 1 site in Turkey (Türkiye).
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 5 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: looking for participants now, as of the sponsor's last update on 2 Feb 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demet Altun, Professor (00905326811767, drdemetaltun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Thickening Fraction (%) (time frame: Following premedication and prior to anesthesia induction, and within the first hour after surgery during the postoperative recovery period.). 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 2 Feb 2026.