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

NCT07311499 | Not Yet Recruiting

• 4 other identifiers: No. 259124K14058202430036Diversity initiatives
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Lung Disease

Keywords

COPD; inhalation management education; sleep quality

Outcome Measures

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.

  Baseline, 2months and 3months

Secondary Outcomes (9)

• Japanese Version of Epworth Sleepiness Scale：JESS

  B0aseline, 2months and 3months

• Apnea-Hypopnea Index

  Baseline and 3 months

• Depth of REM sleep

  Baseline and 3months

• ODI

  Baseline and 3months

• Nocturnal hypoxemia

  Baseline and 3months

Study Arms (2)

education intervention group

ACTIVE COMPARATOR

Behavioral: inhalation management education

Normal care group

NO INTERVENTION

Provide a pamphlet tailored to the patient's inhalation device.

Interventions

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.

education intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kumamoto University: lead
• Hiroshima University: collaborator

Study Sites (1)

Kumamoto University

Kumamoto, Chuo-ku, 862-0976, Japan

Location

Related Publications (17)

• Moriyama M, Takeshita Y, Haruta Y, Hattori N, Ezenwaka CE. Effects of a 6-month nurse-led self-management program on comprehensive pulmonary rehabilitation for patients with COPD receiving home oxygen therapy. Rehabil Nurs. 2015 Jan-Feb;40(1):40-51. doi: 10.1002/rnj.119. Epub 2013 Aug 6.

  PMID: 23922290 RESULT

• Al-Kalaldeh M, El-Rahman MA, El-Ata A. Effectiveness of Nurse-Driven Inhaler Education on Inhaler Proficiency and Compliance Among Obstructive Lung Disease Patients: A Quasi-Experimental Study. Can J Nurs Res. 2016 Jun;48(2):48-55. doi: 10.1177/0844562116676119.

  PMID: 28841042 RESULT

• Sauriasari R, Madani RA, Rozaliyani A, Sudiana D. The effect of repeated education using live demonstrations and videos of how to use inhalation drugs on quality of life for COPD patients. Heliyon. 2021 Aug 24;7(9):e07870. doi: 10.1016/j.heliyon.2021.e07870. eCollection 2021 Sep.

  PMID: 34504968 RESULT

• Muller T, Muller A, Hubel C, Knipel V, Windisch W, Cornelissen CG, Dreher M. Optimizing inhalation technique using web-based videos in obstructive lung diseases. Respir Med. 2017 Aug;129:140-144. doi: 10.1016/j.rmed.2017.06.009. Epub 2017 Jun 17.

  PMID: 28732821 RESULT

• Ngo CQ, Phan DM, Vu GV, Dao PN, Phan PT, Chu HT, Nguyen LH, Vu GT, Ha GH, Tran TH, Tran BX, Latkin CA, Ho CSH, Ho RCM. Inhaler Technique and Adherence to Inhaled Medications among Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Vietnam. Int J Environ Res Public Health. 2019 Jan 10;16(2):185. doi: 10.3390/ijerph16020185.

  PMID: 30634631 RESULT

• Ahn JH, Chung JH, Shin KC, Jin HJ, Jang JG, Lee MS, Lee KH. The effects of repeated inhaler device handling education in COPD patients: a prospective cohort study. Sci Rep. 2020 Nov 12;10(1):19676. doi: 10.1038/s41598-020-76961-y.

  PMID: 33184428 RESULT

• Lindh A, Theander K, Arne M, Lisspers K, Lundh L, Sandelowsky H, Stallberg B, Westerdahl E, Zakrisson AB. One additional educational session in inhaler use to patients with COPD in primary health care - A controlled clinical trial. Patient Educ Couns. 2022 Sep;105(9):2969-2975. doi: 10.1016/j.pec.2022.05.013. Epub 2022 May 26.

  PMID: 35672192 RESULT

• Bouloukaki I, Tzanakis N, Mermigkis C, Giannadaki K, Moniaki V, Mauroudi E, Michelakis S, Schiza SE. Tiotropium Respimat Soft Mist Inhaler versus HandiHaler to improve sleeping oxygen saturation and sleep quality in COPD. Sleep Breath. 2016 May;20(2):605-12. doi: 10.1007/s11325-015-1259-y. Epub 2015 Sep 25.

  PMID: 26407963 RESULT

• Krachman SL, Vega ME, Yu D, Demidovich J, Patel H, Jaffe F, Soler X, Shariff T, D'Alonzo GE, Chatila W, Weaver S, Daraz Y, Cohen S, Criner GJ. Effect of Triple Therapy with Budesonide-Formoterol-Tiotropium Versus Placebo-Tiotropium on Sleep Quality in Patients with Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2021 Apr 27;8(2):219-229. doi: 10.15326/jcopdf.2020.0178.

  PMID: 33610139 RESULT

• Sulaiman I, Seheult J, Sadasivuni N, MacHale E, Killane I, Giannoutsos S, Cushen B, Mokoka MC, Bhreathnach AS, Boland F, Reilly RB, Costello RW. The Impact of Common Inhaler Errors on Drug Delivery: Investigating Critical Errors with a Dry Powder Inhaler. J Aerosol Med Pulm Drug Deliv. 2017 Aug;30(4):247-255. doi: 10.1089/jamp.2016.1334. Epub 2017 Mar 9.

  PMID: 28277810 RESULT

• 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. 2019 Dec;13(12):751-757. doi: 10.1111/crj.13085. Epub 2019 Aug 30.

  PMID: 31449723 RESULT

• Czerwaty K, Dzaman K, Sobczyk KM, Sikorska KI. The Overlap Syndrome of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease: A Systematic Review. Biomedicines. 2022 Dec 21;11(1):16. doi: 10.3390/biomedicines11010016.

  PMID: 36672523 RESULT

• Azuma M, Chin K, Yoshimura C, Takegami M, Takahashi K, Sumi K, Nakamura T, Nakayama-Ashida Y, Minami I, Horita S, Oka Y, Oga T, Wakamura T, Fukuhara S, Mishima M, Kadotani H. Associations among chronic obstructive pulmonary disease and sleep-disordered breathing in an urban male working population in Japan. Respiration. 2014;88(3):234-43. doi: 10.1159/000366064. Epub 2014 Aug 22.

  PMID: 25171691 RESULT

• Climaco DCS, Lustosa TC, Silva MVFP, Lins-Filho OL, Rodrigues VK, Oliveira-Neto LAP, Feitosa ADM, Queiroga FJP Jr, Cabral MM, Pedrosa RP. Sleep quality in COPD patients: correlation with disease severity and health status. J Bras Pneumol. 2022 Apr 29;48(3):e20210340. doi: 10.36416/1806-3756/e20210340. eCollection 2022.

  PMID: 35508063 RESULT

• Lin L, Song Q, Duan J, Liu C, Cheng W, Zhou A, Peng Y, Zhou Z, Zeng Y, Chen Y, Cai S, Chen P. The impact of impaired sleep quality on symptom change and future exacerbation of chronic obstructive pulmonary disease. Respir Res. 2023 Mar 30;24(1):98. doi: 10.1186/s12931-023-02405-6.

  PMID: 36998013 RESULT

• Shorofsky M, Bourbeau J, Kimoff J, Jen R, Malhotra A, Ayas N, Tan WC, Aaron SD, Sin DD, Road J, Chapman KR, O'Donnell DE, Maltais F, Hernandez P, Walker BL, Marciniuk D, Kaminska M; Canadian Respiratory Research Network; CanCOLD Collaborative Research group. Impaired Sleep Quality in COPD Is Associated With Exacerbations: The CanCOLD Cohort Study. Chest. 2019 Nov;156(5):852-863. doi: 10.1016/j.chest.2019.04.132. Epub 2019 May 28.

  PMID: 31150638 RESULT

• Kwon JS, Wolfe LF, Lu BS, Kalhan R. Hyperinflation is associated with lower sleep efficiency in COPD with co-existent obstructive sleep apnea. COPD. 2009 Dec;6(6):441-5. doi: 10.3109/15412550903433000.

  PMID: 19938967 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Asuka Hashino

CONTACT

+81-96-373-5479; hasuka@kumamoto-u.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)