Status Approved
First Submitted Date
2020/12/18
Registered Date
2020/12/29
Last Updated Date
2021/05/18
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005709 |
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Unique Protocol ID | CNUH-2020-318 |
Public/Brief Title | Mask-DISE |
Scientific Title | The effect of type of mask on CPAP and DISE parameters |
Acronym | Mask-DISE |
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 |
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Board Approval Number | CNUH-2020-318 |
Approval Date | 2020-10-29 |
Institutional Review Board Name | Chonnam National University Hospital BIomedical Research Institute |
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 | |
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Name | hyunchae yang |
Title | Assistant professor |
Telephone | +82-62-220-6776 |
Affiliation | Chonnam National University Hospital |
Address | jebonglo-42, Dong-gu, Gwang-ju |
Contact Person for Public Queries | |
Name | hyunchae yang |
Title | Assistant professor |
Telephone | +82-62-220-6776 |
Affiliation | Chonnam National University Hospital |
Address | jebonglo-42, Dong-gu, Gwang-ju |
Contact Person for Updating Information | |
Name | hyunchae yang |
Title | Assistant professor |
Telephone | +82-62-220-6776 |
Affiliation | Chonnam National University Hospital |
Address | jebonglo-42, Dong-gu, Gwang-ju |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2020-11-06 Actual | |
Target Number of Participant | 30 | |
Primary Completion Date | 2021-03-16 , Actual | |
Study Completion Date | 2021-03-16 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chonnam National University Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2020-11-06 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
Project ID | CNUH-2020-318 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Purpose : This study aims to compare the effectiveness of relief of obstruction in the upper airway's anatomical areas according to the type of mask. Background : Obstructive Sleep Apnea is a common sleep-related breathing disorder affecting the adult aged 40 to 70 in the Republic of South Korea, with the prevalence rate of 16% in women and 27% in men. The number of people treated for sleep disorders ranges from 228,000 in 2008 to 357,000 in 2012 in the last five years. This rate was increased 1.57 times, averaging 11.9% annually. The total medical expenses were 19.5 billion won in 2008 and surged to 35.3 billion won in 2012. Untreated OSA can lead to serious medical consequences such as cardiovascular, cerebrovascular, and psychoneurological problems. These increasing complications will result in an average of $1950 to $3899 additional medical expenses per patient in a year. Thus, these indirectly give rise to the socio-economic burden. Sleep-related breathing disorder is recognized as a chronic disease that requires comprehensive management in the long run. The primary definitive treatment is via PAP therapy. It is first proposed in the year 2018 in the Republic of South Korea that the health insurance covers the treatment with PAP. OSA is defined as repetitive narrowing or blockage of the upper airway (UA) during sleep. Therefore, PAP therapy's mechanism is by splinting the upper airway with applied positive pressure to prevent the narrowing through a mask. CPAP therapy is generally known to be the primary treatment for OSA. However, the long-term compliance rate is measured at about 40% worldwide, and it is reported to be even lower in the Republic of South Korea. Drug Induced Sleep Endoscopy(DISE) is a procedure performed by induces the patient to a natural sleep using an appropriate sedative anaesthetics. During the process, the snoring pattern is observed, and the multi-level sites of the UA are inspected endoscopically. These sites include nasal septum, adenoids, soft palate, pharynx, tonsils, tongue base, and epiglottis. This procedure is useful for looking for obstruction sites and determining the appropriate necessary therapy according to the level. Besides that, simulation maneuvers such as jaw thrust, application of PAP device, oral appliance therapy, and positional therapy can be done on the patients to check for UA's improvement during DISE. Although PAP therapy is the definitive treatment for patients with sleep-related breathing disorders, low compliance rates remain the main concern. The mask may have an effect on patient compliance. A randomized crossover study by Mortimore et al. which showed that 20 patients with moderate to severe OSA have 1-hour lower adherence in the oronasal mask than to nasal CPAP during the CPAP titration for four weeks duration each. 19 out of the 20 participants also preferred the nasal mask. Therefore, we want to investigate and confirm the upper airway oronasal mask's effect (full face mask) in this study. The investigation steps would be performing DISE in all patients suspected of sleep apnea, followed by continuous positive airway pressure (CPAP). Each mask is used to assess the anatomical sites of the UA. In addition, the pressure-relieving sites of obstruction with each mask are also documented. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | Medical Device |
Intervention Description | A randomized crossover study was conducted. It is divided into two groups: Group 1 and Group 2. This study's main principle is the random assignment of the groups by simple random allocation (simple randomization). The program used is Random allocation software version 1.0 Group 1 - Group 1 is the patient on the nasal mask during CPAP-DISE. The patient will be wearing the nasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increases, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value. Confirm the pressure which improves the anatomical obstruction sites by the method of 2cmH20 up/1cmH20 down. - Once completion of nasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above. Group 2 - Group 2 is the patient on the oronasal mask during CPAP-DISE. The patient will be wearing the oronasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increase, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value. Confirm the pressure which improves the anatomical obstruction sites by a method of 2cmH20 up/1cmH20 down. - Once completion of oronasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above. |
Number of Arms | 2 |
Arm 1 |
Arm Label Nasal mask- oronasal mask |
Target Number of Participant 15 |
|
Arm Type Experimental |
|
Arm Description Group 1 is the patient on the nasal mask during CPAP-DISE. The patient will be wearing the nasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increases, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value. Confirm the pressure which improves the anatomical obstruction sites by the method of 2cmH20 up/1cmH20 down. - Once completion of nasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above. |
|
Arm 2 |
Arm Label Oronasal mask-nasal mask |
Target Number of Participant 15 |
|
Arm Type Active comparator |
|
Arm Description Group 2 is the patient on the oronasal mask during CPAP-DISE. The patient will be wearing the oronasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increase, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value. Confirm the pressure which improves the anatomical obstruction sites by a method of 2cmH20 up/1cmH20 down. - Once completion of oronasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (G00-G99)Diseases of the nervous system (G47.30)Obstructive sleep apnoea Sleep Apnea, Obstructive |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
Description -Patients over the age of 18 -Symptoms of severe snoring or sleep apnea which warrant indication for polysomnography -Patients who agreed to drug-induced sleep endoscopy -Patients who voluntarily agree to participate in this study |
|
Exclusion Criteria |
-Pregnant or lactating women -Pulmonary disease, severe lung disease, neuromuscular disease, heart failure, and multiple comorbidities -Patients who disagree for polysomnography and DISE -Patients who are contraindicated for DISE such as those with central sleep apnea, restless leg syndrome, parasomnias |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | - To determine the CPAP pressure value on the resolution of obstruction in the anatomical sites of UA according to the Velum, Oropharynx, Tongue base and Epiglottis (VOTE) classification with DISE |
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Timepoint | Drug Induced Sleep Endoscopy |
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Secondary Outcome(s) 1 | ||
Outcome | To examine each anatomical sites of UA according to VOTE at each positive pressure during DISE |
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Timepoint | Drug Induced Sleep Endoscopy |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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