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Trial record 6 of 9 for:    Recruiting, Not yet recruiting, Available Studies | "Arnold-Chiari Malformation"

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

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ClinicalTrials.gov Identifier: NCT03074747
Recruitment Status : Not yet recruiting
First Posted : March 9, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Tongren Hospital

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.


Condition or disease Intervention/treatment
Organic Obstructive Sleep Apnea (Diagnosis) Questionnaire Chiari Malformation Diagnostic Test: questionnaires

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Comparison of Different Questionnaires for Preoperative Screening and Perioperative Risk Prediction in Obstructive Sleep Apnea Patients in China
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: questionnaires
    After filled the questionnaires, the patients will receive the PSG monitoring


Primary Outcome Measures :
  1. Berlin questionnair [ Time Frame: From randomization to complete PSG monitor, assessed up to 3 months ]
    The final reports of the questionnaire

  2. ASA Checklist [ Time Frame: From randomization to complete PSG monitor, assessed up to 3 months ]
    The final reports of the questionnaire

  3. STOP Questionnaire [ Time Frame: From randomization to complete PSG monitor, assessed up to 3 months ]
    The final reports of the questionnaire

  4. STOP-Bang Scoring Model [ Time Frame: From randomization to complete PSG monitor, assessed up to 3 months ]
    The final reports of the questionnaire


Secondary Outcome Measures :
  1. PSG monitor [ Time Frame: on the day of PSG reservation or before operation ]
    golden standard for OSA diagnosis


Other Outcome Measures:
  1. Medical history [ Time Frame: From randomization to complete PSG monitor, assessed up to 3 months ]
    to learn about the medical history

  2. upper airway assessment [ Time Frame: From randomization to complete PSG monitor, assessed up to 3 months ]
    for the difficult airway evaluate and management

  3. 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

  4. continuous pulse oximetry monitor [ Time Frame: postoperative 24 hours, continuous ]
    To monitor the saturation after surgery for the first 24 h



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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

Publications of Results:

Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03074747     History of Changes
Other Study ID Numbers: CT2016
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arnold-Chiari Malformation
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Congenital Abnormalities
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations