A Study on Improving Sleep Quality in COPD Patients Through Inhalation Management Education by Nurses Using Video Conferencing Tools.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Kumamoto University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The Japanese version of the Pittsburgh Sleep Quality Index： PSQI-J
Study Overview
Brief 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.
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】
- Aged 20 years or older at the time of informed consent.
- Prescribed inhaled medications and have used them continuously for at least one month.
- No prior experience with inhalation therapy required.
- No hospitalization for COPD exacerbation within one month prior to study enrollment.
- 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.
- 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.
- Individuals deemed to be in a stable condition by a physician and who have obtained permission.
【exclusion criterias】
- Presence of other respiratory diseases such as asthma or interstitial pneumonia.
- Presence of advanced cancer, including lung cancer.
- Restricted chest movement due to chest deformity or trauma
- Sleep-disordered breathing with a central apnea-hypopnea index (AHI) exceeding 50%.
- Sleep-disordered breathing with a central AHI of more than half
- Diagnosis of dementia or other psychiatric disorders.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- COPD assessment test: CAT(Baseline, 2months and 3months)
- Japanese Version of Epworth Sleepiness Scale：JESS(B0aseline, 2months and 3months)
- Depth of REM sleep(Baseline and 3months)
- Arousals per hour (arousal index)(Baseline and 3months)
- Apnea-Hypopnea Index(Baseline and 3 months)
- Nocturnal hypoxemia(Baseline and 3months)
- Number of technical errors(Baseline, 2months and 3 months)
- ODI(Baseline and 3months)
- Hospital Anxiety and Depression Scale: HADS(Baseline, 2months and 3months)