Obstructive Sleep Apnea Risk ManagementNCT06430957
OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia
An observational study of Obstructive Sleep Apnea Risk Management and Postoperative Complications, run by Kırıkkale University at 2 sites in Turkey (Türkiye).
Trial summary
Obstructive sleep apnea (OSA) is a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea Risk Management, Postoperative Complications, Dental Caries Under General Anesthesia
- What is being tested?
- The STOP-BANG questionnaire for determining OSA risk level., ASA recommended criteria for determining OSA risk level. and Record of postoperative complications
- How many people
- 240 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 28 Jun 2024to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-80 years who applied to the anesthesia clinic for dental procedures planned to be performed under general anesthesia and who had no previous diagnosis of OSA.
Who may be able to join
- Patients between 18-80 years of age who apply to the anesthesia clinic for dental procedures planned to be performed under general anesthesia
- Patients without a previous diagnosis of OSA
Who cannot join
- Individuals who do not want to participate in the study
- Patients previously diagnosed with OSA
- Necessity of emergency surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Erciyes University Faculty of Dentistry
Kayseri
Dilek Günay Canpolat, dgcanpolat@gmail.com
- Recruiting
Kırıkkale University Faculty of Dentistry
Kirikkale
Gözde Nur Erkan, +903182244927 ext. 7140, dr.gozdenur@gmail.com
About this study
Official title: Evaluation of OSA Risk Levels in the Preoperative Period of Adult Patients With Planned Dental Procedures Under Anesthesia and Correlation With Postoperative Complications; A Multicenter Study
Obstructive sleep apnea (OSA) is a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. In OSA patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. However, it is reported that a significant percentage of OSA patients remain undiagnosed. ASA (American Society of Anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of OSA and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. In addition, the STOP-BANG assessment scale, which is widely used all over the world in OSA risk assessment, is also used in OSA risk assessment. It is thought that dental caries and extraction needs may be higher in OSA patients, especially since open-mouth sleeping accompanies the situation. In this respect, it is also important for patients to be diagnosed with OSA as it may prevent dental damage due to open-mouth sleeping in the future. Identifying patients at risk for OSA and directing them to the diagnostic process is very important for patient safety. Within the scope of the study, the criteria recommended by ASA and STOP-BANG score will be evaluated and recorded. Risk stratification in terms of STOP-BANG questionnaire and ASA criteria will be done separately for each patient and for each classification method. Patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. In addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time.
- Conditions
- Obstructive Sleep Apnea Risk Management, Postoperative Complications, Dental Caries Under General Anesthesia, Obstructive Sleep Apnea of Adult
- Being tested
- The STOP-BANG questionnaire for determining OSA risk level., ASA recommended criteria for determining OSA risk level., Record of postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The STOP-BANG questionnaire for determining OSA risk level.Other
An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician.
ASA recommended criteria for determining OSA risk level.Other
An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician.
Record of postoperative complicationsOther
Respiratory complications as laryngospasm/bronchospasm, apnea, hypoxia, duration and amount of need for additional oxygen support and recovery time (duration of modified aldrete score of 9 and above) will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group lowSTOP-B | Study group including patients in the low-risk group in the assessment to be made with STOP-BANG questionnaire. Receives: Other: The STOP-BANG questionnaire for determining OSA risk level.; Other: Record of postoperative complications | |
| Group intermediateSTOP-B | Study group including patients in the medium-risk group in the assessment to be made with STOP-BANG questionnaire. Receives: Other: The STOP-BANG questionnaire for determining OSA risk level.; Other: Record of postoperative complications | |
| Group highSTOP-B | Study group including patients in the high-risk group in the assessment to be made with STOP-BANG questionnaire. Receives: Other: The STOP-BANG questionnaire for determining OSA risk level.; Other: Record of postoperative complications | |
| Group noneASA | The study group that includes patients who are not at risk for OSA in the evaluation with the criteria recommended by the ASA. Receives: Other: ASA recommended criteria for determining OSA risk level.; Other: Record of postoperative complications | |
| Group mildASA | Study group including patients in the mild-risk group for OSA in the evaluation with the criteria recommended by the ASA. Receives: Other: ASA recommended criteria for determining OSA risk level.; Other: Record of postoperative complications | |
| Group moderateASA | Study group including patients in the moderate-risk group for OSA in the evaluation with the criteria recommended by the ASA. Receives: Other: ASA recommended criteria for determining OSA risk level.; Other: Record of postoperative complications | |
| Group severeASA | Study group including patients in the severe-risk group for OSA in the evaluation with the criteria recommended by the ASA. Receives: Other: ASA recommended criteria for determining OSA risk level.; Other: Record of postoperative complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of OSA risk levels of patients
The STOP-BANG questionnaire and the criteria recommended by the ASA, which are recommended to be used routinely worldwide to determine OSA risk level, will be questioned in each patient. Patients with moderate and high risk scores from the STOP-BANG questionnaire and patients with significant OSA risk level according to ASA criteria will be referred to the pulmonology department and further evaluation will be requested. If deemed necessary by the Pulmonology department, a sleep test will be performed. With the sleep test result, the OSA risk level of the patients will be classified as none, mild, moderate and severe in terms of ASA criteria.
Measured: Preoperative period
Postoperative respiratory complications
Respiratory complications including laryngospasm/bronchospasm, apnea, hypoxia that may develop in the postoperative period in patients, the duration of the need for additional oxygen support above the expected duration will be observed and recorded.
Measured: For 4 hours after the end of surgery
Follow-up of indicators of airway obstruction
As indicators of airway obstruction; snoring/whistling respiration, hypertension and intercostal/sternal retractions will be observed and recorded in the study follow-up form.
Measured: For 4 hours after the end of surgery
Duration of recovery
Duration of recovery (modified aldrete score of 9 and above) will be recorded
Measured: For 30 minutes after the end of surgery
Secondary outcomes (1)
Comparison of the effectiveness of STOP-BANG questionnaire and ASA criteria in determining OSA risk level
Patients who will receive an intermediate or high risk score from either of the two assessment questionnaires will be referred for further evaluation and diagnosis of suspected OSA. At the end of the diagnostic process, it is planned to investigate which of the two scoring systems more successfully identifies patients with OSA and assigns a higher risk.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start28 Jun 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 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 Risk ManagementStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Gözde Nur Erkan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430957
- Sponsor's protocol ID
- KU-ERKAN-002
- Status last verified
- Aug 2025
- First submitted
- 14 May 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of OSA Risk Levels in the Preoperative Period of Adult Patients With Planned Dental Procedures Under Anesthesia and Correlation With Postoperative Complications; A Multicenter Study
- ClinicalTrials.gov ID
- NCT06430957
- Acronym / sponsor ID
- KU-ERKAN-002
- Conditions
- Obstructive Sleep Apnea Risk Management, Postoperative Complications, Dental Caries Under General Anesthesia, Obstructive Sleep Apnea of Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 May 2024 (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 a sleep-related respiratory dysfunction. The prevalence of OSA is increasing with the increasing rates of obesity and elderly population worldwide. Perioperative anesthesia management should be adjusted to improve patient safety in patients with OSA. In OSA patients, positive pressure ventilation support may be required in the preoperative period, various ventilation strategies may be required in the intraoperative period, different pharmacologic agents may need to be avoided, and intensive care unit follow-up or noninvasive ventilation support may be required in the postoperative period. However, it is reported that a significant percentage of OSA patients remain undiagnosed. ASA (American Society of Anesthesiologists) has reported the criteria that should be questioned in order to determine the risk of patients in terms of OSA and to initiate the diagnostic process in risky patients and to make appropriate anesthesiologic arrangements in the perioperative period. In addition, the STOP-BANG assessment scale, which is widely used all over the world in OSA risk assessment, is also used in OSA risk assessment. It is thought that dental caries and extraction needs may be higher in OSA patients, especially since open-mouth sleeping accompanies the situation. In this respect, it is also important for patients to be diagnosed with OSA as it may prevent dental damage due to open-mouth sleeping in the future. Identifying patients at risk for OSA and directing them to the diagnostic process is very important for patient safety. Within the scope of the study, the criteria recommended by ASA and STOP-BANG score will be evaluated and recorded. Risk stratification in terms of STOP-BANG questionnaire and ASA criteria will be done separately for each patient and for each classification method. Patients at high risk will be consulted to the relevant medical department in the preoperative period for further investigation and treatment. In addition, it is aimed to correlate the risk levels determined in the study with postoperative respiratory complications and recovery time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group lowSTOP-B | – | Other: The STOP-BANG questionnaire for determining OSA risk level., Other: Record of postoperative complicationsStudy group including patients in the low-risk group in the assessment to be made with STOP-BANG questionnaire. |
| Group intermediateSTOP-B | – | Other: The STOP-BANG questionnaire for determining OSA risk level., Other: Record of postoperative complicationsStudy group including patients in the medium-risk group in the assessment to be made with STOP-BANG questionnaire. |
| Group highSTOP-B | – | Other: The STOP-BANG questionnaire for determining OSA risk level., Other: Record of postoperative complicationsStudy group including patients in the high-risk group in the assessment to be made with STOP-BANG questionnaire. |
| Group noneASA | – | Other: ASA recommended criteria for determining OSA risk level., Other: Record of postoperative complicationsThe study group that includes patients who are not at risk for OSA in the evaluation with the criteria recommended by the ASA. |
| Group mildASA | – | Other: ASA recommended criteria for determining OSA risk level., Other: Record of postoperative complicationsStudy group including patients in the mild-risk group for OSA in the evaluation with the criteria recommended by the ASA. |
| Group moderateASA | – | Other: ASA recommended criteria for determining OSA risk level., Other: Record of postoperative complicationsStudy group including patients in the moderate-risk group for OSA in the evaluation with the criteria recommended by the ASA. |
| Group severeASA | – | Other: ASA recommended criteria for determining OSA risk level., Other: Record of postoperative complicationsStudy group including patients in the severe-risk group for OSA in the evaluation with the criteria recommended by the ASA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-80 years who applied to the anesthesia clinic for dental procedures planned to be performed under general anesthesia and who had no previous diagnosis of OSA.
Key inclusion criteria (2 listed)
- Patients between 18-80 years of age who apply to the anesthesia clinic for dental procedures planned to be performed under general anesthesia
- Patients without a previous diagnosis of OSA
Key exclusion criteria (3 listed)
- Individuals who do not want to participate in the study
- Patients previously diagnosed with OSA
- Necessity of emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The STOP-BANG questionnaire for determining OSA risk level.An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician. | Other | Group highSTOP-B, Group intermediateSTOP-B, Group lowSTOP-B |
| ASA recommended criteria for determining OSA risk level.An assessment questionnaire including OSA-related physical characteristics and symptoms and signs to be questioned individually in each patient will be examined by the physician. | Other | Group mildASA, Group moderateASA, Group noneASA, Group severeASA |
| Record of postoperative complicationsRespiratory complications as laryngospasm/bronchospasm, apnea, hypoxia, duration and amount of need for additional oxygen support and recovery time (duration of modified aldrete score of 9 and above) will be recorded. | Other | Group highSTOP-B, Group intermediateSTOP-B, Group lowSTOP-B, Group mildASA, Group moderateASA, Group noneASA, Group severeASA |
Primary outcome
Determination of OSA risk levels of patients
Time frame: Preoperative period
The STOP-BANG questionnaire and the criteria recommended by the ASA, which are recommended to be used routinely worldwide to determine OSA risk level, will be questioned in each patient. Patients with moderate and high risk scores from the STOP-BANG questionnaire and patients with significant OSA risk level according to ASA criteria will be referred to the pulmonology department and further evaluation will be requested. If deemed necessary by the Pulmonology department, a sleep test will be performed. With the sleep test result, the OSA risk level of the patients will be classified as none, mild, moderate and severe in terms of ASA criteria.
Postoperative respiratory complications
Time frame: For 4 hours after the end of surgery
Respiratory complications including laryngospasm/bronchospasm, apnea, hypoxia that may develop in the postoperative period in patients, the duration of the need for additional oxygen support above the expected duration will be observed and recorded.
Follow-up of indicators of airway obstruction
Time frame: For 4 hours after the end of surgery
As indicators of airway obstruction; snoring/whistling respiration, hypertension and intercostal/sternal retractions will be observed and recorded in the study follow-up form.
Duration of recovery
Time frame: For 30 minutes after the end of surgery
Duration of recovery (modified aldrete score of 9 and above) will be recorded
1 secondary outcome
Comparison of the effectiveness of STOP-BANG questionnaire and ASA criteria in determining OSA risk level
Time frame: Perioperative 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 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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 Risk Management and Postoperative Complications, run by Kırıkkale University at 2 sites 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 2 inclusion and 3 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Gözde Nur Erkan, Asst. Prof. (+905054334692, dr.gozdenur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of OSA risk levels of patients (time frame: Preoperative period). The study lists 4 primary outcomes in all. 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 20 Mar 2026.