A Study on Improving Sleep Quality in COPD Patients Through Inhalation Management Education by Nurses Using Video Conferencing Tools.
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Sponsor: Kumamoto University

Approval number: No. 2591 
11/6/2025 
 
 
 
 
 
 
 
A study on improving sleep quality in COPD patients through inhalation 
management education by nurses using video conferencing tools 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Asuka Hahino 
Department of Nursing, Faculty of Life sciences, 
Kumamoto University 
Tel：(+81)96-373-5479 

Approval number: No. 2591 
11/6/2025 
 
 
E-mail：hasuka@kumamoto-u.ac.jp 
Ⅰ．Background and Significance of the Study 
COPD is associated with sleep-disordered breathing (SDB) due to multiple factors, 
including airflow obstruction and lung hyperinflation in the emphysematous type  
[Know et al, 2009], hypercapnia caused by reduced ventilation during sleep [Lee et al, 
2019] and nocturnal SaO2 levels below 90%[Czerwaty et al, 2022]. Many patients with 
COPD have been reported to exhibit a tendency toward impaired sleep quality [Azuma, 
2014. Climaco, 2022]. 
 In Japan as well, it has been demonstrated that reduced sleep quality among male 
urban workers with COPD is significantly associated with sleep-disordered breathing 
(SDB) [Azuma, 2014]. Poor sleep quality in patients with COPD is associated with 
worsening health status [Lin, 2023. Shorofsky, 2019], increases the risk of exacerbations, 
and hampers symptomatic improvement [Lin, 2023]. Although appropriate interventions 
to improve sleep quality are warranted, healthcare providers have relatively few 
opportunities to address sleep status or the daytime consequences of poor sleep in this 
patient population. 
Bronchodilators, the mainstay of COPD treatment, are predominantly administered via 
inhalation, allowing direct delivery to the lungs and thereby ensuring therapeutic 
efficacy while minimizing systemic side effects. Bronchodilators, such as β2-agonists and 
anticholinergic agents, have been reported to increase FEV1 and improve average 
nocturnal SaO₂. However, incorrect inhalation technique may reduce their efficacy, 
leading to insufficient therapeutic effects [Sulaiman, 2016] . Furthermore, some studies 
have reported that improvements in sleep quality, respiratory symptoms, and quality of 
life (QOL) were not achieved [Krachman, 2021. Bouloukaki, 2015]. In recent years, with 
the diversification of inhalation devices and the increasing use of multiple inhaled 
medications, the prevalence of inhaler misuse has been reported to range between 37% 
to 75% [Lindh, 2022. Ahn, 2020. Ngo, 2019. Muller, 2017]. Furthermore, even after 
receiving education on inhalation techniques, 63.6% of patients continued to misuse 
inhalers [sauriasari, 2021], highlighting the importance of repeated instruction, 
particularly for elderly patients and those with COPD receiving multiple medications. 
Inhaler technique education is a crucial component of COPD management, and it should 
be delivered not only by pharmacists but also by nurses.  
Previous studies [Sauriasari, 2021. Al-Kalaldeh, 2016] have primarily focused on the 
technical aspects of inhalation techniques. However, in nurse-led disease management 
education—which encompasses a wide range of topics such as disease education, 
nutritional management, and responses to exacerbations [Moriyama, 2010] —it cannot 

Approval number: No. 2591 
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be said that sufficient education is being provided regarding the appropriate use and 
administration of inhaled medications. Furthermore, patient education and guidance, 
which were traditionally delivered face-to-face, have increasingly incorporated 
information and communication technologies (ICT), such as telephone consultations, 
online videos, and mobile applications, particularly since the COVID-19 pandemic. 
Nevertheless, there are no existing reports evaluating the effectiveness of video 
conferencing for inhalation management education. 
 Based on the above, the central academic question of this study is whether inhalation 
management education provided by nurses via video conferencing can improve sleep 
quality in patients with COPD. By clarifying this relationship and examining the impact 
of inhalation management education, we aim to develop an effective educational program 
tailored to the specific characteristics of COPD patients. We believe that conducting this 
study will help maximize the therapeutic benefits of current treatments, thereby 
contributing to improved sleep quality, symptom alleviation, and enhanced quality of life 
(QOL), even among individuals with this chronic progressive disease. 
Furthermore, since many COPD patients are elderly and may experience difficulty 
accessing medical facilities due to transportation challenges, this study may offer 
insights into enabling continuous care, regular technical assessments, and appropriate 
treatment even during outbreaks of emerging infectious diseases such as COVID-19. 
 
Ⅱ．Objective 
To investigate whether providing two sessions of patient education on inhalation 
technique and self-management via video conferencing, in addition to continuous 
inhalation therapy, improves sleep quality and quality of life in COPD patients compared 
to standard self-care support. 
 
Ⅲ．Methods 
１．Study Design 
A multicenter, block-randomized controlled trial involving patients with COPD. 
 
２．Study Participants and Eligibility Criteria 
Patients in the stable phase of chronic obstructive pulmonary disease (COPD) who 
regularly attend Kumamoto University Hospital, Konan Hospital, or Iwakuni Municipal 
Nishiki Central Hospital, all of which provide internal medicine and respiratory care, 
will be eligible for participation in this study. Eligible participants must meet all of the 
inclusion criteria and none of the exclusion criteria listed below. 

Approval number: No. 2591 
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(1) Inclusion Criteria 
1. Individuals aged 20 years or older at the time of obtaining informed consent. 
2. Individuals who have been prescribed and continuously using inhaled medications 
for more than one month. 
3. No restrictions regarding previous experience with inhalation instruction. 
4. No hospitalizations due to COPD exacerbation within one month prior to study 
participation. 
5. Individuals with coexisting obstructive sleep apnea syndrome (OSAS) and 
undergoing treatment with continuous positive airway pressure (CPAP) may be 
included, provided their symptoms are stable following CPAP initiation. 
6. Individuals capable of operating a device such as an Android tablet, iPad, or 
personal computer. However, participants may still be eligible if a caregiver can 
operate the device on their behalf. 
7. Individuals who have received approval from their attending physician. 
[Justification for Inclusion Criteria] 
1. The minimum age for participants to make an informed decision about joining this 
study was set at 20 years old. 
2. 3. Based on prior research, participants were defined as those receiving continuous 
inhaled medication therapy for at least one month, not new patients. 
4. In cases of hospitalization due to COPD exacerbation, the first month post-
discharge is difficult to assess whether symptoms like dyspnea or bronchodilator 
effects stem from the recovery process or inhaler management education. 
Therefore, the one-month mark, when symptoms are considered stable, was set as 
the starting point. 
5. If symptoms are stable (fixed) after OVS diagnosis and CPAP initiation, the 
bronchodilator effect from proper inhaler use is considered independent of OVS 
presence and thus acceptable. If OSAS suspicion arises during pre-enrollment 
screening and is subsequently diagnosed, treatment takes priority. After 
consultation with the primary physician, the study will commence 3-6 months 
after CPAP initiation. 
6. This requirement was established because the intervention in this study utilizes 
video conferencing. Participants unable to operate devices for video conferencing 
(e.g., Skype, Zoom) would necessitate unnecessary contact, potentially increasing 
participant burden and introducing bias. 
7. This was established as a necessary requirement for conducting this study. 

Approval number: No. 2591 
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(2) Exclusion Criteria 
Participants will be excluded if they meet any of the following criteria: 
1. Presence of other respiratory diseases such as asthma or interstitial pneumonia. 
2. Diagnosis of advanced cancer, including lung cancer. 
3. Restricted thoracic mobility due to thoracic deformities or trauma. 
4. Presence of diseases that cause dyspnea, such as cardiac disorders. 
5. Sleep-disordered breathing in which central apnea–hypopnea index (AHI) accounts 
for the majority of events. 
6. Diagnosis of dementia or psychiatric disorders. 
[Justification for Exclusion Criteria] 
1. This criterion is intended to ensure accurate assessment of the effects of the 
educational intervention specific to COPD patients. Asthma will be definitively 
excluded through a fractional exhaled nitric oxide (FeNO) test at the time of study 
enrollment. 
2. Advanced cancer may affect sleep quality due to psychological stress or disease 
burden, which could confound the study results. 
3. In cases where thoracic movement is restricted, dyspnea may not respond to 
bronchodilation from inhaled medications, limiting the ability to assess 
intervention effectiveness. 
4–5. Symptoms such as breathlessness caused by cardiac disease or central sleep 
apnea are unlikely to improve through the pharmacological effects of inhaled 
bronchodilators, making it difficult to evaluate the intervention’s effectiveness. 
6. Exclusion of participants with psychiatric or cognitive disorders is necessary to 
avoid potential confounding effects on sleep quality and to ensure participants can 
make autonomous decisions regarding study participation. 
 
3. Subject Registration 
After approval by the Kumamoto University Ethics Committee, the principal 
investigator or co-investigator/collaborator will receive referrals of patients meeting 
the eligibility criteria from the attending physicians at the collaborating research 
institutions. The principal investigator or co-investigator/collaborator will then 
provide an explanation of the study at the date, time, and location specified by the 
patient. The purpose, significance, methods, and ethical considerations of the study 
will be explained verbally and in writing, and written informed consent will be 
obtained. After obtaining consent, contact the Principal Investigator to obtain a 
subject identification code and register the subject in the study. 

Approval number: No. 2591 
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4. Allocation Method 
Stratified block allocation will be used, with gender (male, female) and severity 
classification (Grade 1, 2, 3, 4) as allocation factors. Allocation of subjects to each 
treatment group will be performed by Makiko Yamamoto at the Department of Basic 
Nursing Science, Kumamoto University Graduate School. 
   Following a pre-generated random allocation table, subjects will be sequentially 
assigned to treatment groups in the order of case registration. A registration 
confirmation document listing the subject registration number and group name will 
be issued. The allocation table will be retained by the person responsible for allocation 
and will not be disclosed to the Principal Investigator or Co-Investigators. 
 
5. Target Sample Size and Rationale 
Target Sample Size: 
• 
Intervention group: 30 participants 
• 
Control group: 40 participants 
• 
Total: 60 participants 
Rationale for Sample Size: 
There are no previous studies that have specifically examined the impact of 
inhalation management education on sleep quality. In prior studies, the mean PSQI 
(Pittsburgh Sleep Quality Index) scores among patients with COPD ranged from 8.3 
to 11.5, with a commonly used cutoff score of 5.5 to indicate poor sleep quality. Based 
on this, we assumed a mean reduction of 5.0 points in the PSQI-J score at 3 months in 
the intervention group. 
Using a two-tailed test with a significance level of 5% (α = 0.05) and a power of 80% 
(β = 0.20), the required sample size was calculated to be 17 participants per group. 
However, considering that many participants are older adults who may face 
challenges in consistently using personal computers or video conferencing tools, a 
higher dropout rate than usual is expected. Therefore, we increased the target 
enrollment to 30 participants per group, for a total of 60 participants. 
 
6. Research Outline 
After obtaining research consent, baseline attributes, inhalation technique checks, 
and pre-intervention sleep assessments are conducted. For the pre-intervention 
assessment, a Watch Pad 200U or 300 is loaned to participants, who wear it overnight 
at home to record sleep onset. 
After random assignment, the intervention group undergoes two inhalation technique 

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checks and inhalation management education sessions during an 8-week follow-up 
period. At the study's conclusion, participants undergo an inhalation technique check, 
sleep assessment, and questionnaire survey. If inhalation technique errors persist after 
training completion and the participant requests it, inhalation management education 
will be provided post-study. For the control group, these technique checks and education 
involve sending a pamphlet on using the same device as their prescribed inhaled 
medication at enrollment or approximately one week after enrollment, followed by an 
inhalation technique check via video conference. After a 12-week observation period, the 
study concludes with an inhalation technique check, sleep assessment, and 
questionnaire completion at the study end. Additionally, inhalation management 
education will be provided after the study concludes if the participant requests it. 
 
7．Intervention 
The intervention content for the education intervention group is described below. 
The usual care group will receive only the same pamphlet as the intervention group, 
without any explanation or instruction on inhalation techniques. 
First Intervention Session (within one month of participant enrollment): 
1) During a video conference, the participant will be asked to use their prescribed 
inhaled medication while the study staff (applicant) observes their inhalation 
technique. The staff will assess the technique using a standardized technical 
checklist. Feedback will be provided based on the assessment, and any technical 
errors will be corrected through demonstration of the correct inhalation method. 

Approval number: No. 2591 
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2) Education will be provided on self-management, including how to use inhaled 
medications in response to symptoms such as dyspnea and cough perceived in daily 
life, appropriate timing of inhalation, and self-monitoring strategies. 
Second Intervention Session (four weeks after the first session): 
1) During a video conference, the participant will again demonstrate inhalation using 
their prescribed inhaler, observed by the study staff who will assess technique with 
the checklist. Feedback will be given, and any technical errors will be addressed 
through correct method demonstration. 
2) The staff will inquire about any difficulties or symptoms experienced by the 
participant since the previous intervention, and discuss inhaler use and 
management strategies together with the participant. 
 
8. Evaluation Items 
(1) Primary Evaluation Item 
Improvement in the Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J) 
[Rationale]   
The PSQI (Pittsburgh Sleep Quality Index) is a scale for evaluating sleep quality. It 
is the most widely used and standardized measure globally, employed in numerous 
clinical trials. A Japanese version, PSQI-J, has also been developed. Since this study 
aims to examine sleep quality improvement as an effect of inhalation management 
education, this scale was selected as the primary outcome measure. 
The PSQI-J is a questionnaire assessing sleep status over the past month. It consists 
of 19 self-reported items and seven subscales: Sleep Quality, Sleep Onset, Sleep 
Duration, Sleep Efficiency, Sleep Difficulty, Sleep Medication Use, and Daytime 
Sleepiness. A total score ranging from 0 to 3 points (0–21 points total) is calculated, 
with higher scores indicating greater sleep impairment. 
Assessment timepoints were at participant registration, the second intervention 
session, and study completion. 
 
(2) Secondary Evaluation Items 
1) Sleep Quality 
① Japanese Version of Epworth Sleepiness Scale (JESS) 
[Rationale] 
JESS is a scale used to assess subjective daytime sleepiness and diagnose sleep 
disorders. It has been modified with items tailored to Japanese lifestyles, and its 
reliability and validity in the Japanese population have been verified. Similar to PSQI-

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J, since nighttime sleep conditions are thought to influence daytime sleepiness and 
related states, we will evaluate improvements in subjective symptoms using JESS. 
Assessment points are set at: before the first intervention, during the second 
intervention, and at the end of the observation period. 
Respondents answer eight questions using a 4-point scale: “0 points” for “Very 
unlikely to doze off” and “3 points” for “Very likely to doze off.” A total score of 11 points 
or higher indicates a high likelihood of sleep apnea syndrome. 
②Nighttime Sleep Assessment (AHI, ODI3%, ODI4%, average nighttime SpO2, time 
with nighttime SpO2 <90%, arousal status) 
【Rationale】 
Bronchodilator effects of β2 agonists, anticholinergic agents, and inhaled 
corticosteroids, along with improvements in nighttime SaO2 and AHI, have been 
reported. In this study, it is presumed that correct inhalation implementation 
enhances drug efficacy and further improves nocturnal sleep status. Therefore, these 
parameters were set as secondary endpoints for objective evaluation.  
Watch PAT continuously measures peripheral arterial blood flow throughout the 
night and calculates AHI, ODI, nocturnal hypoxia, arousals, and REM sleep depth. In 
studies comparing Watch PAT to PSG, strong correlations were confirmed for AHI and 
RDI measurements (r=0.889 [95% CI; 0.862-0.911]; P<0.001). Watch PAT enables 
objective sleep assessment without requiring measurements in non-routine settings 
like hospitals and without burdening subjects. Assessment points are at participant 
enrollment and at the end of the observation period. 
③Japanese Version of CAT (COPD Assessment Test) 
【Rationale】 
The St George's Respiratory Questionnaire (SGRQ) is a respiratory disease-specific 
QOL measure developed for COPD patients. However, it contains 80 items and takes 
approximately 20 minutes to complete. In contrast, the CAT was developed as a 
shorter, simpler questionnaire to assess the impact of COPD on patients' lives. It 
shows good correlation with the SGRQ (r=0.80, p<0.0001). Furthermore, the Japanese 
version of the CAT, adapted to the Japanese lifestyle, also demonstrated high internal 
consistency (Cronbach's alpha: 0.891), a high correlation with the SGRQ (r ≈ 0.82, 
p<0.001), and showed a correlation with the general health-related QOL questionnaire 
(SF-12v2). Therefore, this study will use the Japanese version of the CAT to assess 
patient QOL. The assessment points were set at the time of participant registration 
and at the end of the observation period, in accordance with the CAT Policy Committee 
and the GOLD Strategy Document. 

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The assessment uses an 8-item scale (cough, sputum production, breathlessness, 
dyspnea on exertion, daily activities, confidence in going out, sleep, and energy) rated 
on a 6-point scale from 0 to 5, with a total score out of 40. A higher total score indicates 
a worsening health status. 
2) Items related to inhalation technique 
① Number and content of technical errors assessed using the inhalation technique 
checklist 
[Rationale] 
To evaluate whether the intervention enabled patients to perform inhalation 
correctly using device-specific checklists. The inhalation technique checklists were 
developed based on prior research. Evaluation points are after the first intervention, 
before and after the second intervention, and at the end of the observation period. 
 
9. Observation and Examination Items and Schedule 
In this study, the following information will be collected from the participant at the 
time of enrollment, at the time of intervention, and at the end of the study, either 
through direct interview with the participant or by retrieving it from medical records 
with the participant's permission. Sleep evaluation will be measured for research 
purposes (research funding). 
At the time of enrollment 
[Patient Basic Information] 
Patient Background: Age, Gender, Smoking History, BMI, Disease Duration, Alcohol 
Consumption (presence/absence and frequency), Use of Sleep 
Medications, Hospitalization within the Past 6 Months, Presence of 
Comorbidities (e.g., Diabetes, Heart Disease, Stroke, Hypertension, 
Depression, Cognitive Impairment), mMRC, Types and Number of 
Inhaled Medications 
Respiratory Function: FVC (ml), FEV1 (ml), FEV1/FVC (%), %FEV1 (%) measured 
between 6 months prior to enrollment and the first intervention 
Sleep assessment: AHI, ODI, snoring level, wakefulness/sleep depth, REM sleep 
structure, oxygen saturation (mean minimum oxygen saturation, 
frequency of oxygen saturation drops, heart rate during sleep) using 
Watch Pad 200U or 300 
Inhalation therapy experience: Presence/absence of inhalation therapy instruction and 
details (providing profession, time since last instruction, past 
instruction method [demonstration, video, pamphlet, verbal]) 

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[Self-Administered Questionnaire I] 
Anxiety/Depression Tendencies: Japanese Version of the Hospital Anxiety and 
Depression Scale (HADS) 
QOL: Japanese Version of the CAT 
Sleep Quality: PSQI-J, JESS 
Initial Intervention: Within one month of participant registration 
Inhalation Technique: Assessment using the Inhalation Technique Checklist 
・Presence of technical errors 
Second Intervention: Approximately 4 weeks after initial intervention 
Inhalation Technique: Assessment using Inhalation Technique Checklist 
       ・Presence of technical errors 
       ・Changes to device, medication content, or frequency and reasons 
［Self-Report Questionnaire II］ 
Sleep Quality: PSQI-J, JESS 
Anxiety/Depression Tendencies: HADS 
Study Completion (Approximately 8 weeks after second intervention) 
Inhalation Technique: Assessment using Inhalation Technique Checklist 
       ・Presence of technical errors 
       ・Changes in device, medication type, or dosage frequency and their 
reasons 
Sleep Assessment: AHI, ODI, snoring level, arousal/sleep depth, body position, REM 
sleep structure, oxygen saturation statistics (mean minimum oxygen 
saturation, frequency of oxygen saturation drops, heart rate during 
sleep) using Watch Pad 200U or 300 
[Self-Report Questionnaire III] 
Sleep Quality: PSQI-J, JESS 
QOL: Japanese CAT 
Anxiety/Depression Tendencies: HADS 
Presence of unscheduled visits or hospitalizations from enrollment to study completion 
[Brochure] 
Self-assessment of inhaler usage, inhalation log (symptoms of breathlessness, 
cough/phlegm, self-rated sleep) 
 
 
 
 

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Table1. Inspection Schedule 
 
within 
6weeks 
registrati
on 
Initial 
intervent
ion 
Second 
intervent
ion 
At 
the 
completi
on of the 
research 
Cancella
tion 
Pulmonary Function 
Test 
〇 
 
 
 
 
 
Patient Basic Attributes 
 
〇 
 
 
 
 
QOL（Quality of life） 
 
〇 
 
〇 
〇 
△ 
PSQI・JESS  
（Sleep quality） 
 
〇 
 
〇 
〇 
△ 
Sleep Assessment 
（Sleep study） 
 
〇 
 
 
〇 
△ 
Check of inhalation 
technique 
 
〇※ 
〇※ 
〇 
〇 
△ 
HADS 
(Anxiety and Depressive 
Tendencies) 
 
〇 
 
〇 
〇 
△ 
Unplanned medical 
visits or hospitalizations 
 
 
 
 
〇 
△ 
Observation of adverse 
events 
 
 
 
 
 
△ 
Inhalation Management 
Log 
 
 
 
 
〇 
△ 
“○” indicates required items; “△” indicates optional items;  
“※” indicates items to be completed during registration or around the time of the first  
intervention. 
 
10. Analysis Methods 
1) Analysis of Primary Endpoint 
Primary Endpoint: PSQI-J at 3 months post-educational intervention 
Analysis of the primary endpoint will be performed using the Full Analysis Set 
(FAS). The change in PSQI-J for each group will be calculated, and between-group 
comparisons will be performed at a 5% significance level (two-tailed) using covariance 
analysis adjusted for the background factors of age and disease stage classification. A 
similar analysis will be performed secondarily using PPS as the analysis population. 
2) Secondary Outcome Measure Analysis 
Outcome Measures: Using the FAS as the analysis population, comparisons of the 
mean change in JESS, nocturnal sleep assessments (AHI, ODI, nocturnal hypoxia, 
arousal status, etc.), and Japanese CAT scores between groups will be tested at a 5% 
significance level. A similar analysis will be performed secondarily using PPS as the 
analysis population. 

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Safety Assessment: Not applicable 
 
11. Study Period 
Registration Period: Study Approval Date ~ June 30, 2026 
(Last Observation Date for Last Patient: ~ December 31, 2026) 
Implementation Period (Total Study Period): Study Approval Date ~ March 31, 2030 
 
12. Informed Consent Documents and Methods for Obtaining Subject Consent 
The Principal Investigator or Co-Investigator shall provide the research subject with 
the informed consent document approved by the Kumamoto University Clinical 
Research Ethics Review Committee (hereinafter referred to as the Ethics Review 
Committee) and authorized by the head of the research institution. They shall provide 
a thorough explanation both verbally and in writing and obtain the research subject's 
written informed consent freely given. Furthermore, when information regarding 
efficacy, safety, or other factors that could influence the research subject's consent is 
obtained, or when changes to the implementation plan or other aspects that could 
affect the research subject's consent are made, the research team shall promptly 
provide this information to the research subject. The research team shall confirm the 
research subject's intention regarding participation in the research in advance. The 
research team shall also revise the explanatory document, etc., after obtaining prior 
approval from the Ethics Review Committee and permission from the head of the 
research institution, and obtain renewed consent from the research subject. 
 
13. Ethical Considerations 
1) Applicable Regulations 
This study complies with the World Medical Association's “Declaration of Helsinki 
(latest version)” and the “Ethical Guidelines for Life Science and Medical Research 
Involving Human Subjects (Ministry of Education, Culture, Sports, Science and 
Technology, Ministry of Health, Labor and Welfare, Ministry of Economy, Trade and 
Industry Notice No. 1 of 2021)” issued by the Ministry of Education, Culture, Sports, 
Science and Technology, the Ministry of Health, Labor and Welfare, and the Ministry 
of Economy, Trade and Industry. 
 
2) Handling of Personal Information 
To protect the personal information of research subjects, utmost care will be 
exercised in its handling. All case reports, documents, correspondence, specimens, etc., 

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will have names and medical record numbers removed. For questionnaires and survey 
forms, a reference table will be created, and research subjects will be assigned unique 
identification codes for handling. Only data in a state where individuals cannot be 
identified will be collected for this research. 
Furthermore, any attempt to identify specific individuals from processed samples or 
information that has been rendered non-identifiable without reasonable justification 
is prohibited. Data containing assigned identification codes shall be managed and 
analyzed on a PC located in a strictly secured room (Room 405, Building E, 
Department of Health Sciences, Kumamoto University School of Medicine). Access 
shall be restricted by password, and measures against unauthorized software shall be 
implemented to prevent unauthorized external access. 
Documents that are not anonymized, such as consent forms, shall be stored in a 
lockable cabinet in Room 405, Building E, Department of Health Sciences, Kumamoto 
University School of Medicine. 
Furthermore, information that could identify individuals shall not be disclosed in 
reports or presentations of research results. 
 
14. Research Funding and Conflict of Interest 
1) Funding Sources 
This research is conducted using funding from the Kumamoto University Diversity 
Project (Collaborative Research Project) for fiscal years 2023 and 2025, Grants-in-Aid 
for Scientific Research (Grant Number 24K14058), and the Mitsubishi Foundation 
Grant for Social Welfare Research. 
2) Researchers' Conflict of Interest 
No researcher has received financial benefits or other related benefits from 
companies or organizations with potential conflicts of interest in this research. Conflict 
of interest matters are managed by the Kumamoto University Clinical Research 
Conflict of Interest Management Committee. 
3) Cost Burden for Research Participants 
For standard self-care support in this study, no fees related to medical treatment 
will be charged. Costs for examinations and other procedures related to conducting the 
research will be covered by the research funds. 
Both the intervention and control groups will receive inhalation technique checks 
via video call, incurring communication fees for the video conferencing. Video calls are 
estimated to last approximately 30 minutes for the control group and 60 minutes for 
the intervention group receiving inhalation management education. We plan to use 

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Zoom or Skype for video calls. Data usage is estimated at approximately 300MB for 30 
minutes and 600MB for 60 minutes. Although video conferences occur only once per 
month, since most carriers charge ¥1,100 (tax included) for each 1GB of additional 
data, we consider it appropriate for the researcher to cover these costs. 
Therefore, we will pay compensation that includes these communication fees as part 
of the honorarium for participating in this study. 
4) Compensation 
Participants who assist with the research will receive compensation in the form of a 
Quo Card or Amazon gift card worth 10,000 yen. Payment will be made by mail or 
handed directly by the researcher after the 3-month study period ends, with a receipt 
obtained. Compensation will not be requested back if participation is withdrawn after 
the study concludes. 
 
15. Methods for Storing and Disposing of Samples and Information, and Secondary Use 
1) Methods for Storing and Disposing of Samples and Information 
(1) Sample Storage 
Samples obtained during the research period (including subjects' medical 
information) shall be stored in a lockable cabinet in Room 405, Building E, Kumamoto 
University. The storage period shall be the later of: 5 years from the date the 
completion of the research was reported, or 3 years from the date the final publication 
of the research results was reported. After the storage period ends, the samples shall 
be disposed of anonymously using appropriate methods. 
Samples obtained during the research will be stored as anonymized processed 
information, making it impossible to identify the source, for potential future research. 
When utilizing this information for future research, it will be disclosed in a manner 
allowing research subjects to opt out, following approval by the Ethics Review 
Committee.  
(2) Information Storage 
Information obtained during the research period shall be stored on the principal 
investigator's personal computer and in a locked room in Room 405, Building E, 
Kumamoto University. The retention period shall be the later of either: five years from 
the date the completion of the research is reported, or three years from the date the 
final publication of the research results is reported. After the retention period ends, 
the information shall be disposed of appropriately while maintaining its anonymized 
state. 
(3) Storage of Records and Documents 

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Documents related to the implementation of this research (copies of application 
documents, notification documents, copies of various application forms and reports, 
research subject identification code lists, consent forms, copies of case report forms, 
and other documents or records necessary to ensure data reliability) shall be retained 
for a period ending on the later of either five years after the date the completion of the 
research was reported or three years after the date the final publication of the research 
results was reported. After the retention period ends, the documents shall be 
anonymized and disposed of by appropriate means. 
 
16. Secondary Use of Samples and Information 
Samples and information obtained from research subjects in this study may 
potentially be used in research on sleep quality in patients with COPD and OSA 
overlap syndrome, or in studies investigating the effects of long-term inhalation 
management education. In such cases, a new research protocol will be prepared, 
reviewed by the Ethics Review Committee, and implemented only upon approval. 
When providing samples or information to other research institutions, the head of 
the institution will be notified, and the materials will be provided only after 
anonymization. 
 
17. References 
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efficiency in COPD with co-existent obstructive sleep apnea. COPD: Journal of 
Chronic Obstructive Pulmonary Disease 6(6) 441-445, 2009 
2) Lee SH, Kim KU, Lee H, Park HK, Kim YS, Lee MK. Sleep disturbance in patients 
with mild-moderate chronic obstructive pulmonary disease. Clin Respir J 13
（12）:751-757, 2019 
3) Czerwaty K, Dżaman K, Sobczyk KM, Sikorska KI. The Overlap Syndrome of 
Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease: A Systematic 
Review. Biomedicines 11(1):16, 2022. 
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