Improvement of Sleep in COPD Patients Through Inhalation Management Education by Nurse.

December 21, 2025 updated by: Kumamoto University

A Study on Improving Sleep Quality in COPD Patients Through Inhalation Management Education by Nurses Using Video Conferencing Tools.

This study aims to investigate whether inhalation management education provided by nurses improves sleep quality in patients with COPD. Inhalation management education includes training in inhalation techniques and guidance on how to use medications when symptoms occur.

The main research question is:

・Does inhalation management education improve sleep quality in patients with COPD?

Researchers will determine whether inhalation management education improves sleep quality compared to no education.

Participants will:

  • Participate in two interviews with researchers using video conferencing tools.
  • Keep a diary recording their symptoms, sleep duration, and the frequency of rescue inhaler use.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

●Research participants, eligibility criteria, and exclusion criteria The study will include stable COPD patients who are outpatients at Kumamoto University Hospital, Kounan Hospital, or Iwakuni City Nishiki Central Hospital, which specialize in internal and respiratory medicine. Eligible participants must meet all of the following criteria and must not meet any exclusion criteria.

【Eligibility Criteria】

  1. Aged 20 years or older at the time of informed consent.
  2. Prescribed inhaled medications and have used them continuously for at least one month.
  3. No prior experience with inhalation therapy required.
  4. No hospitalization for COPD exacerbation within one month prior to study enrollment.
  5. Patients with obstructive sleep apnea (OSAS) overlap syndrome (OVS) receiving nasal continuous positive airway pressure (CPAP) therapy are eligible if their symptoms are stable, as determined by a physician after CPAP initiation.
  6. Able to operate a device such as an Android tablet, iPad, or computer; if not, participation is still acceptable if a caregiver can operate the device.
  7. Individuals deemed to be in a stable condition by a physician and who have obtained permission.

【exclusion criterias】

  1. Presence of other respiratory diseases such as asthma or interstitial pneumonia.
  2. Presence of advanced cancer, including lung cancer.
  3. Restricted chest movement due to chest deformity or trauma
  4. Sleep-disordered breathing with a central apnea-hypopnea index (AHI) exceeding 50%.
  5. Sleep-disordered breathing with a central AHI of more than half

  6. Diagnosis of dementia or other psychiatric disorders.

    • Registration of study subjects The attending physician at the collaborating research institution will refer patients who meet the eligibility criteria for the study, and the principal investigator or research collaborator will obtain the patient's consent directly. The purpose and significance of the study, the methods, and ethical considerations will be explained verbally and in writing, and written consent will be obtained. After obtaining consent, a study subject identification code will be assigned, and the study subject will be registered in this study.
    • Allocation method A stratified block allocation will be performed using gender (male, female) and severity classification (GOLD Grade 1, 2, 3, 4) as allocation factors. The allocation of study participants to each treatment group will be conducted by Makiko Yamamoto at the Department of Basic Nursing Science, Kumamoto University Graduate School of Nursing.

    Following the pre-established random allocation table, participants will be sequentially assigned to each treatment group in the order of case registration, and a registration confirmation form will be issued, indicating the participant's registration number and treatment group. The allocation table will be retained by the allocation officer and will not be disclosed to the principal investigator or co-investigators.

    ●Sample size Target number of participants (Total: 34 cases) Intervention group: 17 cases Control group: 17 cases Number of participants expected to enroll(Total: 60 cases) Intervention group: 30 cases Control group: 30 cases There are no previous studies measuring the effect of inhalation management education on sleep quality. In previous studies, the average PSQI score for COPD patients was 8.3-11.5 points, and the PSQI cutoff value is 5.5 points. Assuming a change of 5.0 points in the average PSQI-J score after 3 months in the intervention group, the sample size required to maintain a two-sided test (significance level 5%) with 80% power is 17 cases per group. Considering that many participants are elderly and may have difficulty continuing to use computers or video conferencing tools, a higher dropout rate than usual is anticipated. Therefore, 30 participants per group, totaling 60 participants, will be enrolled in the study.

    ●Criteria for exclusion from analysis The definition of the analysis population is as follows.

    -Full Analysis Set (FAS) The FAS consists of all study subjects who provided informed consent, excluding the following study subjects.

    • Cases that do not meet the primary eligibility criteria (e.g., diagnosed with a disease outside the scope of the study, or found to have violated objectively determinable selection or exclusion criteria) • Cases with no post-randomization measurements -The population compliant with the study protocol (Per Protocol Set: PPS)

    The PPS is defined as the FAS excluding the following subjects:

    • Cases with unavailable measurements of the primary endpoint

    • Cases with major protocol violations (e.g., allocation errors, failure to meet eligibility criteria, non-compliance with medication)

    This study will clearly identify the breakdown of cancellations and dropouts by compiling data on the number of registered subjects who were excluded from the analysis population and the reasons for their exclusion, broken down by analysis population.

    ●Analysis and statistical methods for verifying evaluation items Statistical analysis will be performed using JMP Pro 18, with a significance level set at 5%.

    -Analysis of primary endpoints Primary endpoint: Change in PSQI-J at 3 months before and after the educational intervention The primary endpoint will be analyzed using the FAS. The change in PSQI-J scores will be calculated for each group, and independent t-tests will be performed to compare groups at a significance level (two-sided) of 5%. A similar analysis will be conducted using PPS as the analysis population as a secondary analysis.

    -Using FAS as the analysis population, the difference in the mean change in JESS, Japanese CAT, and HADS scores between groups will be analyzed using a paired t-test at a significance level of 5%. Similar analyses will also be conducted using PPS as the analysis population.

    In this study, baseline data for the primary outcome measure, PSQI, were missing at study registration. If PSQI-J was measured within one month of baseline (prior to the first intervention), that data was used to impute baseline data for PSQI-J. This method of data imputation may result in the presence of data from different measurement time points at baseline.

    However, since the PSQI-J reflects sleep quality over the past month and no interventions were conducted during that period, this method of data supplementation is considered appropriate. For other items, missing values will not be supplemented.

    Information on patients obtained at baseline from participants who withdrew from the study or withdrew their consent will be used for analysis if consent is obtained from the participants themselves, as it constitutes valuable data on inhalation techniques, inhalation education, and methods for current COPD patients.

    ●Criteria for discontinuing participation in research The principal investigator or co-investigator shall terminate the study if they determine that it is impossible to continue the study for any of the following reasons.

    <Termination Criteria>

    • If a research subject withdraws from the study or revokes their consent

    • If it is determined after registration that the subject no longer meets the eligibility criteria (inclusion/exclusion criteria)

    • If the subject requires emergency hospitalization and treatment due to worsening of the underlying disease
    • If the study cannot be continued due to worsening of complications
    • If the study cannot be continued due to adverse events
    • If the study is terminated
    • If the physician determines that termination of the study is appropriate for other reasons

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Chuo-ku
      • Kumamoto, Chuo-ku, Japan, 862-0976
        • Kumamoto University
        • Principal Investigator:
          • Asuka Hashino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged 20 years or older at the time of consent.
  • Individuals who have been prescribed inhaled medications and have been using them continuously for more than one month.
  • Prior experience with inhalation instruction is not required.
  • Individuals who have not been hospitalized within one month prior to study participation due to exacerbation of COPD.
  • Individuals with obstructive sleep apnea syndrome (OSAS) who are receiving treatment with continuous positive airway pressure (CPAP) therapy are eligible, provided that the physician determines that symptoms are stable following CPAP initiation.
  • Participants must be able to operate devices such as Android, iPad, or computer. However, if a caregiver can operate the device, the participant's inability to do so is acceptable.
  • Participants must be in a stable condition as determined by a physician and have obtained permission to participate.

Exclusion Criteria:

  • Suffering from other respiratory diseases such as asthma or interstitial pneumonia
  • Suffering from advanced cancer, including lung cancer
  • Restricted chest movement due to chest deformity or trauma
  • Suffering from diseases that cause respiratory distress, such as heart disease
  • Suffering from sleep-disordered breathing with a central AHI of more than 50%
  • Diagnosed with dementia or mental illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: education intervention group
Behavioral: inhalation management education
  • During interviews with researchers, undergo a technical check. Then, practice inhalation techniques.
  • During interviews with researchers, discuss solutions to symptoms and problems encountered in daily life.
  • Participants implement the solutions decided upon during the observation period.
  • During the second intervention, assess whether the solutions were effective and, if not, consider alternative solutions.
No Intervention: Normal care group
Provide a pamphlet tailored to the patient's inhalation device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Japanese version of the Pittsburgh Sleep Quality Index： PSQI-J
Time Frame: Baseline, 2months and 3months
The PSQI-J is a questionnaire that asks about sleep patterns over the past month. It consists of 19 self-reported items and seven factors: sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep difficulty, use of sleep medication, and daytime sleepiness. A total score of 0 to 3 points (0 to 21 points) is calculated, and the higher the score, the more severe the sleep disorder is considered to be.
Baseline, 2months and 3months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Japanese Version of Epworth Sleepiness Scale：JESS
Time Frame: B0aseline, 2months and 3months
This is a self-assessment of the degree of sleepiness in eight daily-life situations. Each item is scored from 0 to 3(0-24 points), with higher total scores indicating greater daytime sleepiness. If the total score is 11 or higher, it is likely that the patient has SAS (sleep apnea syndrome).
B0aseline, 2months and 3months
Apnea-Hypopnea Index
Time Frame: Baseline and 3 months
Apnea-Hypopnea Index(AHI) is an index used to evaluate sleep apnea syndrome (SAS). It is calculated as the total number of observed apneas and hypopneas during sleep divided by the total sleep time (typically per hour). Diagnose with sleep apnea syndrome based on AHI>5.
Baseline and 3 months
Depth of REM sleep
Time Frame: Baseline and 3months
During REM sleep, estimates include the number and duration of wakefulness episodes and the proportion of REM time spent awake. The more times it occurs, the more it is considered to be disrupting sleep.
Baseline and 3months
ODI
Time Frame: Baseline and 3months
ODI (Oxygen Desaturation Index) is the number of oxygen desaturation events per hour of sleep. The number of events per hour in which SpO₂ drops by a certain percentage, usually 3% or 4%. Usually it's zero times.
Baseline and 3months
Nocturnal hypoxemia
Time Frame: Baseline and 3months
Nocturnal hypoxemia is characterized by mean overnight oxygen saturation (mean SpO₂) during sleep, minimum oxygen saturation (minimum SpO₂) observed during sleep, percentage of time with SpO2<90%(% of total sleep time, %TST). We will investigate how much the SpO2 level decreases during a single sleep period and the duration of that decrease.
Baseline and 3months
Arousals per hour (arousal index)
Time Frame: Baseline and 3months
Arousals is an assessment of wakefulness events during sleep. The more times it occurs, the more it is thought to lead to a decline in sleep quality.
Baseline and 3months
COPD assessment test: CAT
Time Frame: Baseline, 2months and 3months
This questionnaire is designed for the simple assessment of symptoms and the impact on daily life in patients with COPD. It consists of eight items, each scored from 0 to 5. Higher scores indicate more severe symptoms and greater impact on daily life.
Baseline, 2months and 3months
Hospital Anxiety and Depression Scale: HADS
Time Frame: Baseline, 2months and 3months
The items are designed to be less influenced by physical symptoms, making them valid for patients with medical conditions. The total score for each is 0-21 points. A total score of 8 or more for odd numbers is considered a state of anxiety, and a total score of 11 or more for even numbers is considered a state of depression.
Baseline, 2months and 3months
Number of technical errors
Time Frame: Baseline, 2months and 3 months
For each inhalation device, the items in which the participant performs an incorrect inhalation technique are considered errors, and the number of such items is counted.
Baseline, 2months and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kumamoto University

Collaborators

Hiroshima University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 2591
  • 24K14058 (Other Grant/Funding Number: Japan Society for the Promotion of Science)
  • 202430036 (Other Grant/Funding Number: The Mitsubishi Foundation)
  • Diversity initiatives (Other Grant/Funding Number: Kumamoto University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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