Organic Obstructive Sleep Apnea (Diagnosis)COQNCT03074747
Comparison of Four Questionnaires for OSA Screening in China
An observational study of Organic Obstructive Sleep Apnea (Diagnosis) and Questionnaire, run by Beijing Tongren Hospital.
Trial summary
Background: Obstructive sleep apnea (OSA) refers to the apnea and hypopnea caused by upper airway obstruction during sleep. Patients are associated with sleep disorders, frequent desaturation, hypertension, coronary heart disease, cerebrovascular disease and diabetes. OSA prevalence increased in China in recent years. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Organic Obstructive Sleep Apnea (Diagnosis), Questionnaire, Chiari Malformation
- What is being tested?
- questionnaires
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Dec 2018
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Participants for this study will be recruited Beijing Tongren Hospital scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in ENT sleep center. 2. To accept OSA correction surgery (UPPP). 3. To receive the ophthalmological surgery under general anesthesia.
Who may be able to join
- Adult (18-60ys)
- Male
- ASA Ⅰ～Ⅲ grade
- Applie to receive PSG monitor in sleep center
- Plan to receive ophthalmological surgery under general anesthesia
- To accept OSA correction surgery (UPPP)
Who cannot join
- Severe maxillofacial deformities, pharyngeal reconstruction surgery history ( velopharynoplasty, upper and lower jaw orthopedic surgery, cleft lip and palate surgery)
- Disturbance of consciousness, no self-control ability, serious mental illness, long-term alcohol abuse, drug abuse
- Took mental or nervous system drugs within 3 months
- Sleep apnea caused by hypothyroidism, acromegaly, laryngeal spasm, vocal cord paralysis
- Epilepsy, neuromuscular disease
- central sleep apnea
Show all 9Show fewer
- Ventilator treatment before monitor for more than 1 month
- Llliteracy
- Non-Chinese
About this study
Official title: The Comparison of Different Questionnaires for Preoperative Screening and Perioperative Risk Prediction in Obstructive Sleep Apnea Patients in China
Background: Obstructive sleep apnea (OSA) refers to the apnea and hypopnea caused by upper airway obstruction during sleep. Patients are associated with sleep disorders, frequent desaturation, hypertension, coronary heart disease, cerebrovascular disease and diabetes. OSA prevalence increased in China in recent years. It is estimated that nearly 80% of men and 93% of women are not diagnosed for moderate and severe OSA. Anesthesiologists and surgeons paid more attention on those high risk patients. The gold standard for OSA diagnosis is apnea and hypopnea index (AHI) obtained from polysomnography (PSG). But it is difficult to carry out PSG regularly in primary health care institutions in China for its high cost and long waiting list. So many OSA questionnaires are developed in Europe and North America, obesity is an important risk factor for OSA for them. But in China people have different anatomical characteristics, the diagnosis sensitivity and specificity of those methods has not been reported in China.
Methods and Design: Participants for this study will be recruited in Beijing Tongren Hospital scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in sleep center. 2. To receive OSA correction surgery (UPPP). 3. To receive ophthalmological surgery under general anesthesia.
Read more
Detailed inquiry and record all medical history. Upper airway assessment will be recorded. Preoperative snoring questionnaires will be integrated according to the four questionnaires. All patients complete PSG monitor. For patients undergoing surgical treatment, postoperative continuous pulse oximetry will be recorded for 24 hours. All postoperative adverse events will be recorded.
The primary endpoint:
All the patients complete the four snoring questionnaires (ASA, Berlin, STOP and STOP-BANG) before PSG test.
The secondary endpoints:
PSG monitor will be completed before operation. Medical history, upper airway assessment, postoperative 24 hours continuous pulse oximetry monitor and all perioperative adverse events will be recorded.
The purpose is to compare the specificity and sensitivity of four questionnaires to figure out OSA. To find suspected OSA patients before operation with one easy-to-use assessment questionnaire and direct OSA clinical practice.
- Being tested
- questionnaires
- Medical subject headings
- Disease, Arnold-Chiari Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesDiagnostic test
After filled the questionnaires, the patients will receive the PSG monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Berlin questionnair
The final reports of the questionnaire
Measured: From randomization to complete PSG monitor, assessed up to 3 months
ASA Checklist
The final reports of the questionnaire
Measured: From randomization to complete PSG monitor, assessed up to 3 months
STOP Questionnaire
The final reports of the questionnaire
Measured: From randomization to complete PSG monitor, assessed up to 3 months
STOP-Bang Scoring Model
The final reports of the questionnaire
Measured: From randomization to complete PSG monitor, assessed up to 3 months
Secondary outcomes (1)
PSG monitor
golden standard for OSA diagnosis
Measured: on the day of PSG reservation or before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionMar 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Organic Obstructive Sleep Apnea (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074747
- Sponsor's protocol ID
- CT2016
- Acronym
- COQ
- Status last verified
- Mar 2017
- First submitted
- 22 Feb 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stradling JR, Davies RJ. Sleep. 1: Obstructive sleep apnoea/hypopnoea syndrome: definitions, epidemiology, and natural history. Thorax. 2004 Jan;59(1):73-8. doi: 10.1136/thx.2003.007161.
PubMed 14694254Chung SA, Yuan H, Chung F. A systemic review of obstructive sleep apnea and its implications for anesthesiologists. Anesth Analg. 2008 Nov;107(5):1543-63. doi: 10.1213/ane.0b013e318187c83a.
PubMed 18931212Joshi GP, Ankichetty SP, Gan TJ, Chung F. Society for Ambulatory Anesthesia consensus statement on preoperative selection of adult patients with obstructive sleep apnea scheduled for ambulatory surgery. Anesth Analg. 2012 Nov;115(5):1060-8. doi: 10.1213/ANE.0b013e318269cfd7. Epub 2012 Aug 10.
PubMed 22886843Adesanya AO, Lee W, Greilich NB, Joshi GP. Perioperative management of obstructive sleep apnea. Chest. 2010 Dec;138(6):1489-98. doi: 10.1378/chest.10-1108.
PubMed 21138886Turner K, VanDenkerkhof E, Lam M, Mackillop W. Perioperative care of patients with obstructive sleep apnea - a survey of Canadian anesthesiologists. Can J Anaesth. 2006 Mar;53(3):299-304. doi: 10.1007/BF03022219.
PubMed 16527797Mickelson SA. Preoperative and postoperative management of obstructive sleep apnea patients. Otolaryngol Clin North Am. 2007 Aug;40(4):877-89. doi: 10.1016/j.otc.2007.04.007.
PubMed 17606028American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.
PubMed 24346178Fischer MK, Martinez D, Cassol CM, Rahmeier L, Vieira LR. Immediate and overnight recumbence-dependent changes of neck circumference: relationship with OSA severity in obese and nonobese subjects. Sleep Med. 2012 Jun;13(6):650-5. doi: 10.1016/j.sleep.2012.02.007. Epub 2012 Mar 17.
PubMed 22425575Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11.
PubMed 26380759Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. Validation of the Berlin questionnaire and American Society of Anesthesiologists checklist as screening tools for obstructive sleep apnea in surgical patients. Anesthesiology. 2008 May;108(5):822-30. doi: 10.1097/ALN.0b013e31816d91b5.
PubMed 18431117Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.
PubMed 22401881
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Different Questionnaires for Preoperative Screening and Perioperative Risk Prediction in Obstructive Sleep Apnea Patients in China
- ClinicalTrials.gov ID
- NCT03074747
- Acronym / sponsor ID
- COQ / CT2016
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Mar 2017 (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.
Background: Obstructive sleep apnea (OSA) refers to the apnea and hypopnea caused by upper airway obstruction during sleep. Patients are associated with sleep disorders, frequent desaturation, hypertension, coronary heart disease, cerebrovascular disease and diabetes. OSA prevalence increased in China in recent years. It is estimated that nearly 80% of men and 93% of women are not diagnosed for moderate and severe OSA. Anesthesiologists and surgeons paid more attention on those high risk patients. The gold standard for OSA diagnosis is apnea and hypopnea index (AHI) obtained from polysomnography (PSG). But it is difficult to carry out PSG regularly in primary health care institutions in China for its high cost and long waiting list. So many OSA questionnaires are developed in Europe and North America, obesity is an important risk factor for OSA for them. But in China people have different anatomical characteristics, the diagnosis sensitivity and specificity of those methods has not been reported in China.
Methods and Design: Participants for this study will be recruited in Beijing Tongren Hospital scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in sleep center. 2. To receive OSA correction surgery (UPPP). 3. To receive ophthalmological surgery under general anesthesia.
Detailed inquiry and record all medical history. Upper airway assessment will be recorded. Preoperative snoring questionnaires will be integrated according to the four questionnaires. All patients complete PSG monitor. For patients undergoing surgical treatment, postoperative continuous pulse oximetry will be recorded for 24 hours. All postoperative adverse events will be recorded.
The primary endpoint:
All the patients complete the four snoring questionnaires (ASA, Berlin, STOP and STOP-BANG) before PSG test.
The secondary endpoints:
PSG monitor will be completed before operation. Medical history, upper airway assessment, postoperative 24 hours continuous pulse oximetry monitor and all perioperative adverse events will be recorded.
The purpose is to compare the specificity and sensitivity of four questionnaires to figure out OSA. To find suspected OSA patients before operation with one easy-to-use assessment questionnaire and direct OSA clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants for this study will be recruited Beijing Tongren Hospital scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in ENT sleep center. 2. To accept OSA correction surgery (UPPP). 3. To receive the ophthalmological surgery under general anesthesia.
Key inclusion criteria (6 listed)
- Adult (18-60ys)
- Male
- ASA Ⅰ～Ⅲ grade
- Applie to receive PSG monitor in sleep center
- Plan to receive ophthalmological surgery under general anesthesia
Key exclusion criteria (9 listed)
- Severe maxillofacial deformities, pharyngeal reconstruction surgery history ( velopharynoplasty, upper and lower jaw orthopedic surgery, cleft lip and palate surgery)
- Disturbance of consciousness, no self-control ability, serious mental illness, long-term alcohol abuse, drug abuse
- Took mental or nervous system drugs within 3 months
- Sleep apnea caused by hypothyroidism, acromegaly, laryngeal spasm, vocal cord paralysis
- Epilepsy, neuromuscular disease
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 |
|---|---|---|
| questionnairesAfter filled the questionnaires, the patients will receive the PSG monitoring | Diagnostic test | – |
Primary outcome
Berlin questionnair
Time frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
ASA Checklist
Time frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
STOP Questionnaire
Time frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
STOP-Bang Scoring Model
Time frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
1 secondary outcome
PSG monitor
Time frame: on the day of PSG reservation or before operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Results publication: PubMed 14694254Stradling JR, Davies RJ. Sleep. 1: Obstructive sleep apnoea/hypopnoea syndrome: definitions, epidemiology, and natural history. Thorax. 2004 Jan;59(1):73-8. doi: 10.1136/thx.2003.007161.
- Results publication: PubMed 18931212Chung SA, Yuan H, Chung F. A systemic review of obstructive sleep apnea and its implications for anesthesiologists. Anesth Analg. 2008 Nov;107(5):1543-63. doi: 10.1213/ane.0b013e318187c83a.
- Results publication: PubMed 22886843Joshi GP, Ankichetty SP, Gan TJ, Chung F. Society for Ambulatory Anesthesia consensus statement on preoperative selection of adult patients with obstructive sleep apnea scheduled for ambulatory surgery. Anesth Analg. 2012 Nov;115(5):1060-8. doi: 10.1213/ANE.0b013e318269cfd7. Epub 2012 Aug 10.
- Results publication: PubMed 21138886Adesanya AO, Lee W, Greilich NB, Joshi GP. Perioperative management of obstructive sleep apnea. Chest. 2010 Dec;138(6):1489-98. doi: 10.1378/chest.10-1108.
- Results publication: PubMed 16527797Turner K, VanDenkerkhof E, Lam M, Mackillop W. Perioperative care of patients with obstructive sleep apnea - a survey of Canadian anesthesiologists. Can J Anaesth. 2006 Mar;53(3):299-304. doi: 10.1007/BF03022219.
- Results publication: PubMed 17606028Mickelson SA. Preoperative and postoperative management of obstructive sleep apnea patients. Otolaryngol Clin North Am. 2007 Aug;40(4):877-89. doi: 10.1016/j.otc.2007.04.007.
- Results publication: PubMed 24346178American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.
- Results publication: PubMed 22425575Fischer MK, Martinez D, Cassol CM, Rahmeier L, Vieira LR. Immediate and overnight recumbence-dependent changes of neck circumference: relationship with OSA severity in obese and nonobese subjects. Sleep Med. 2012 Jun;13(6):650-5. doi: 10.1016/j.sleep.2012.02.007. Epub 2012 Mar 17.
- Results publication: PubMed 26380759Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11.
- Results publication: PubMed 18431117Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. Validation of the Berlin questionnaire and American Society of Anesthesiologists checklist as screening tools for obstructive sleep apnea in surgical patients. Anesthesiology. 2008 May;108(5):822-30. doi: 10.1097/ALN.0b013e31816d91b5.
- Results publication: PubMed 22401881Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Organic Obstructive Sleep Apnea (Diagnosis) and Questionnaire, run by Beijing Tongren Hospital.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Mar 2017. 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?
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?
Berlin questionnair (time frame: From randomization to complete PSG monitor, assessed up to 3 months). 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?
On the ClinicalTrials.gov record for NCT03074747, which also lists 11 linked publications.
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 13 Mar 2017.