Status Approved
First Submitted Date
2019/09/06
Registered Date
2021/01/07
Last Updated Date
2021/05/18
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005738 |
---|---|
Unique Protocol ID | CNUH-2019-232 |
Public/Brief Title | The effect of partial epiglottectomy on the parameters of positive airway pressure treatment in patients with obstructive sleep apnea |
Scientific Title | The effect of partial epiglottectomy on the parameters of positive airway pressure treatment in patients with obstructive sleep apnea |
Acronym | OSAS-epiglottectomy |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | CNUH-2019-232 |
Approval Date | 2019-08-30 |
Institutional Review Board Name | chonnam national university hospital institutional review board |
Institutional Review Board Address | 42, Jebong-ro, Dong-gu, Gwangju |
Institutional Review Board Telephone | 062-220-5257 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | hyungchae yang |
Title | Dr |
Telephone | +82-62-220-6776 |
Affiliation | Chonnam National University Hospital |
Address | 42 Jebongro dong-gu Gwang-ju |
Contact Person for Public Queries | |
Name | hyungchae yang |
Title | Dr |
Telephone | +82-62-220-6776 |
Affiliation | Chonnam National University Hospital |
Address | 42 Jebongro dong-gu Gwang-ju |
Contact Person for Updating Information | |
Name | hyungchae yang |
Title | Dr |
Telephone | +82-62-220-6776 |
Affiliation | Chonnam National University Hospital |
Address | 42 Jebongro dong-gu Gwang-ju |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Withdrawn | |
Date of First Enrollment | 2019-09-10 Actual | |
Target Number of Participant | 88 | |
Primary Completion Date | 2021-05-18 , Actual | |
Study Completion Date | 2021-05-18 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chonnam National University Hospital | |
Recruitment Status | Withdrawn Withdrawn Reason : 코로나19사태로 인하여 연구대상자 등록및 추적관찰의 어려움 | |
Date of First Enrollment | 2019-09-10 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
Project ID | CNUH-2019-232 |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | The objectives of the study drug induced sleep endoscopy on the epiglottal closure of the obstructive sleep apnea patients who have been found in the ablation patient's quality of life and the quality of the epiglottis.Long and variable used yangapkki jeogeungdo to check the impact on. |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Medical Device, /Procedure/Surgery |
Intervention Description | Group 1 If the drug-induced endoscopic examination confirms the closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, perform a laryngeal partial resection to mitigate the closing of the larynx. For a period (approximately 1 month) waiting before surgery, automatic positive pressure treatment is performed, which is a standard treatment for sleep apnea patients. Conduct a questionnaire that evaluates sleep conditions before and after surgery. Patients in the group start to wear the positive pressure after surgery. After surgery, survey questionnaires and positive pressure usage performance during outpatient tracking after 1, 3, 6, 12 months Group 2 If the drug-induced endoscopy shows closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, conduct a positive pressure test (CPAP titration). Automatic positive pressure treatment is performed until the proper pressure inspection of the positive pressure system is conducted, and continuous positive pressure treatment is performed with the appropriate pressure determined after the proper pressure test of the positive pressure. Collect the questionnaire PSQI and ESS that assess the sleep condition after starting treatment of the constant positive pressure as shown in Group 1. In addition, the results of questionnaires and positive pressure units are investigated for outpatient tracking after 1, 3, 6, 12 months. |
Number of Arms | 2 |
Arm 1 |
Arm Label CPAP Use |
Target Number of Participant 44 |
|
Arm Type Experimental |
|
Arm Description If the drug-induced endoscopy shows closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, conduct a positive pressure test (CPAP titration). Automatic positive pressure treatment is performed until the proper pressure inspection of the positive pressure system is conducted, and continuous positive pressure treatment is performed with the appropriate pressure determined after the proper pressure test of the positive pressure. Collect the questionnaire PSQI and ESS that assess the sleep condition after starting treatment of the constant positive pressure as shown in Group 1. In addition, the results of questionnaires and positive pressure units are investigated for outpatient tracking after 1, 3, 6, 12 months. |
|
Arm 2 |
Arm Label epiglottectomy |
Target Number of Participant 44 |
|
Arm Type Active comparator |
|
Arm Description If the drug-induced endoscopic examination confirms the closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, perform a laryngeal partial resection to mitigate the closing of the larynx. For a period (approximately 1 month) waiting before surgery, automatic positive pressure treatment is performed, which is a standard treatment for sleep apnea patients. Conduct a questionnaire that evaluates sleep conditions before and after surgery. Patients in the group start to wear the positive pressure after surgery. After surgery, survey questionnaires and positive pressure usage performance during outpatient tracking after 1, 3, 6, 12 months |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (G00-G99)Diseases of the nervous system (G47.30)Obstructive sleep apnoea obstructive sleep apnea |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
Description - over the age of 18 - those who suffer from severe snoring or sleep apnea in the polygamous sleep test with AHI > 15 or higher, or those who suffer from severe symptoms among patients with AHI > 5 or higher - those who showed the occipital closure of the larynx during a drug-induced sleep endoscopy - those who voluntarily agreed to participate in this study in writing. |
|
Exclusion Criteria |
- A woman who may be pregnant or pregnant; a nursing woman. - patients with suspected central sleep apnea or other sleep disorders such as insomnia, anxiety syndrome, narcolepsy, circadian disorder, and event sleep - a person who suffers from lung or nerve root diseases or heart failure with a moderate degree or higher, which can lead to reduced accuracy of sleep polydialysis. - those who do not agree with the survey and the multi-sleep test |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | Continuous positive airway pressure(CPAP) score |
|
Timepoint | 1,3,6,12 months |
|
Primary Outcome(s) 2 | ||
Outcome | visual analog scale score(VAS score) |
|
Timepoint | 1,3,6,12 months |
|
Secondary Outcome(s) 1 | ||
Outcome | Korean Version of the Pittsburgh Sleep Quality Index(PSQI-K) |
|
Timepoint | 1,3,6,12 months |
|
Secondary Outcome(s) 2 | ||
Outcome | Korean version of the Epworth sleepness scale(ESS) |
|
Timepoint | 1,3,6,12 months |
|
Secondary Outcome(s) 3 | ||
Outcome | The reflux sumptom index(RSI) |
|
Timepoint | 1,3,6,12 months |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동