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A multi-Centre randomized controlled trial and a case records based retrospective study for effective and safety of multilevel upper airway surgery for OSAHS patients

A multi-Centre randomized controlled trial and a case records based retrospective study for effective and safety of multilevel upper airway surgery for OSAHS patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018130
Enrollment
Unknown
Registered
2018-08-31
Start date
2018-08-20
Completion date
Unknown
Last updated
2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea hypopnea syndrome

Interventions

experimental group:surgery immidiately
control group:Waiting list and surgery six months latter
Group 1: case records based analysis (non-RCT):surgery
Group 2: case records based analysis (non-RCT):CPAP

Sponsors

Nanfang Hospital, Nanfang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criterion of treatment group: 1. The OSAHS patients should be diagnosed by PSG and intolerance by CPAP; 2. Patients should be the candidate of upper airway surgery, age between 18-60 years old male and female; 3. Patients should tolerated general anesthesia with good cardiopulmonary function; 4. They should understand the purpose the clinical trial and sign the informed consent Form. Inclusion criterion of retrospective research: 1. Patients accepted CPAP at the beginning of therapy; 2. They had integrate following up clinical data; 3. They should not have serious cardiopulmonary insufficiency, hepatorenal dysfunction and immune system disease.

Exclusion criteria

Exclusion criteria: Exclusion criterion of treatment group: 1. Patients who can not tolerate surgery with serious cardiopulmonary disease,hepatorenal dysfunction and immune system disease; 2. medical history with pharyngeal surgery; 3. with accute upper respiratory infection; 4. serious OSAHS according to polysomnogram (PSG) report (AHI>70, LSpO240; 6. pregnant or breast feeding female; 7. with more than 10 years diabetes and unstable glycemic level; 8. abnormal cranio facial structure with mandible dysontogenesis or retraction.

Design outcomes

Primary

MeasureTime frame
PSG;

Secondary

MeasureTime frame
blood lipid;blood sugar;inflammatory factor;UA;

Countries

China

Contacts

Public ContactXiangping Li

Nanfang Hospital, Nanfang Medical University

li321162@qq.com+86 13602705825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026