Comparison of Four Questionnaires for OSA Screening in China (COQ)

March 9, 2017 updated by: Beijing Tongren Hospital

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berlin questionnair
Time Frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
From randomization to complete PSG monitor, assessed up to 3 months
ASA Checklist
Time Frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
From randomization to complete PSG monitor, assessed up to 3 months
STOP Questionnaire
Time Frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
From randomization to complete PSG monitor, assessed up to 3 months
STOP-Bang Scoring Model
Time Frame: From randomization to complete PSG monitor, assessed up to 3 months
The final reports of the questionnaire
From randomization to complete PSG monitor, assessed up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSG monitor
Time Frame: on the day of PSG reservation or before operation
golden standard for OSA diagnosis
on the day of PSG reservation or before operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical history
Time Frame: From randomization to complete PSG monitor, assessed up to 3 months
to learn about the medical history
From randomization to complete PSG monitor, assessed up to 3 months
upper airway assessment
Time Frame: From randomization to complete PSG monitor, assessed up to 3 months
for the difficult airway evaluate and management
From randomization to complete PSG monitor, assessed up to 3 months
adverse events
Time Frame: during the induction of anesthesia, the whole period of anesthesia, in PACU and postoperative 24 hours
to record the related adverse events during the perioperative period
during the induction of anesthesia, the whole period of anesthesia, in PACU and postoperative 24 hours
continuous pulse oximetry monitor
Time Frame: postoperative 24 hours, continuous
To monitor the saturation after surgery for the first 24 h
postoperative 24 hours, continuous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

March 4, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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