Status:
UNKNOWN
Effects of Combined Surgery on Obstructive Sleep Apnea in Obese Patients: an Open-label Randomized Controlled Clinical Trial
Lead Sponsor:
Bing Wang
Conditions:
To Compare the Difference of AHI Variation Between LSG and Combined Surgery
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief Summary
This research is created for compare the difference of AHI variation between LSG and combined surgery on obstructive sleep apnea in obese patients , evaluate the risk of combined surgery and explore t...
Detailed Description
Obesity is one of the new health challenges in China and all over the world，Morbidly obesity (MO) is an important risk factor for metabolic diseases and obstructive sleep apnea(OSA), which can be effe...
Eligibility Criteria
Inclusion
- Chinese Han population aged 16 to 65 years
- BMI more than 32.5Kg/㎡ with AHI more than ≥30/hour
- First diagnosed with PSG without any corresponding treatment;
- Adenoid tonsil hypertrophy (Friedman stage II-III).
Exclusion
- Drug abuse, alcohol addiction and mental diseases
- Dysgnosia
- Over-high expectation
- Risk-averse patient;
- Poor tolerance to surgery
- Patient suffering from gastroesophageal reflux and hiatal hernia
- Central or mixed sleep apnea diagnosed by PSG
- PO2\<60mmHg when the patient is awake
- Suffering from maligent tumor, neural system injury and respiratory insufficiency
- Hypothyroidism
- Other special issue decided by specialist.
Key Trial Info
Start Date :
July 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03227939
Start Date
July 25 2017
End Date
May 1 2020
Last Update
July 24 2017
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