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Clinical Trials in Japan / NCT07311499
Starting soon Not applicable

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

NCT07311499 · tracked via the Priya Life Science Japan tracker
Sponsor
Kumamoto University
Phase
Not applicable
Started
2026-01
Last updated
2025-12-31

Condition(s) studied

Chronic Obstructive Lung Disease

Investigational drug(s) / intervention(s)

inhalation management education

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The Japanese version of the Pittsburgh Sleep Quality Index： PSQI-J — 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.

Trial sites (1)

FacilityCityRegionStatus
Kumamoto University Kumamoto Chuo-ku

More Kumamoto University trials in Japan

Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07311499 on ClinicalTrials.gov ↗ ← All trials in Japan