Comparison of Four Questionnaires for OSA Screening in China

NCT ID: NCT03074747

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Organic Obstructive Sleep Apnea (Diagnosis); Questionnaire; Chiari Malformation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

questionnaires

After filled the questionnaires, the patients will receive the PSG monitoring

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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Other Identifiers

CT2016

Identifier Type: -

Identifier Source: org_study_id