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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorKumamoto University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • inhalation management education

    Behavioral

    * 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: education intervention groupActive comparator 1 intervention
Group B: Normal care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Baseline, 2months and 3months

Secondary outcomes

1

Japanese Version of Epworth Sleepiness Scale:JESS

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).

Time frame
B0aseline, 2months and 3months
2

Apnea-Hypopnea Index

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.

Time frame
Baseline and 3 months
3

Depth of REM sleep

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.

Time frame
Baseline and 3months
4

ODI

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.

Time frame
Baseline and 3months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kumamoto University

Lead sponsor

Hiroshima University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: