Clinical trial NCT03074747: Comparison of Four Questionnaires for OSA Screening in China
Official title: The Comparison of Different Questionnaires for Preoperative Screening and Perioperative Risk Prediction in Obstructive Sleep Apnea Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Organic Obstructive Sleep Apnea (Diagnosis)
Questionnaire
Chiari Malformation
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 1200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Adult (18-60ys)
2. Male
3. ASA Ⅰ～Ⅲ grade
4. Applie to receive PSG monitor in sleep center
5. Plan to receive ophthalmological surgery under general anesthesia
6. To accept OSA correction surgery (UPPP)

Exclusion Criteria:

1. Severe maxillofacial deformities, pharyngeal reconstruction surgery history ( velopharynoplasty, upper and lower jaw orthopedic surgery, cleft lip and palate surgery)
2. Disturbance of consciousness, no self-control ability, serious mental illness, long-term alcohol abuse, drug abuse
3. Took mental or nervous system drugs within 3 months
4. Sleep apnea caused by hypothyroidism, acromegaly, laryngeal spasm, vocal cord paralysis
5. Epilepsy, neuromuscular disease
6. central sleep apnea
7. Ventilator treatment before monitor for more than 1 month
8. Llliteracy
9. Non-Chinese

Primary outcomes:
measure: Berlin questionnair
timeFrame: From randomization to complete PSG monitor, assessed up to 3 months
measure: ASA Checklist
timeFrame: From randomization to complete PSG monitor, assessed up to 3 months
measure: STOP Questionnaire
timeFrame: From randomization to complete PSG monitor, assessed up to 3 months
measure: STOP-Bang Scoring Model
timeFrame: From randomization to complete PSG monitor, assessed up to 3 months
Secondary outcomes:
measure: PSG monitor
timeFrame: on the day of PSG reservation or before operation
Other outcomes:
measure: Medical history
timeFrame: From randomization to complete PSG monitor, assessed up to 3 months
measure: upper airway assessment
timeFrame: From randomization to complete PSG monitor, assessed up to 3 months
measure: adverse events
timeFrame: during the induction of anesthesia, the whole period of anesthesia, in PACU and postoperative 24 hours
measure: continuous pulse oximetry monitor
timeFrame: postoperative 24 hours, continuous
Locations:
Study officials:
References:
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