UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052724 |
|---|---|
| Receipt number | R000060158 |
| Scientific Title | Characteristics of sleep disturbances and their association with health-related quality of life in patients with non-tuberculous mycobacterial pulmonary disease |
| Date of disclosure of the study information | 2023/11/07 |
| Last modified on | 2025/03/08 11:12:02 |
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Basic information
Public title
Characteristics of sleep disturbances and their association with health-related quality of life in patients with non-tuberculous mycobacterial pulmonary disease
Acronym
Characteristics of sleep disturbances in patients with non-tuberculous mycobacterial pulmonary disease
Scientific Title
Characteristics of sleep disturbances and their association with health-related quality of life in patients with non-tuberculous mycobacterial pulmonary disease
Scientific Title:Acronym
Characteristics of sleep disturbances in patients with non-tuberculous mycobacterial pulmonary disease
Region
| Japan |
Condition
Condition
non-tuberculous mycobacterial pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prevalence of sleep disturbances and the characteristics of sleep disturbances, as well as their association with HRQoL.
Basic objectives2
Others
Basic objectives -Others
To determine the prevalence of sleep disturbances and the characteristics of sleep disturbances, as well as their association with health-related quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective sleep quality
Key secondary outcomes
Respiratory function
Exercise capacity
Dyspnea
Psycho-Psychological Aspects
Health-related quality of life
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in stable condition who are scheduled to be hospitalized for induction or intensified treatment of non-tuberculous mycobacterial pulmonary disease and for whom physiotherapy is prescribed.
Key exclusion criteria
Cases in which consent could not be obtained.
Cases with communication problems due to cognitive decline or psychiatric disorders.
Patients who have difficulty communicating in Japanese.
Patients with a diagnosis of malignant tumor or sleep apnea.
Cases that require limitation of exercise due to comorbidities or risk of pneumothorax, hemoptysis, etc.
Cases with exacerbation within 4 weeks
Cases in which the principal investigator determines that the subject is inappropriate.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Tabusadani |
Organization
Fukujuji Hospital
Division name
Respiratory Care and Rehabilitation Center
Zip code
204-8522
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo
TEL
042-491-9264
tabusadani@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Toyoda |
Organization
Fukujuji Hospital
Division name
Respiratory Care and Rehabilitation Center
Zip code
204-8522
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo
TEL
042-491-9264
Homepage URL
y.toyoda23@gmai.com
Sponsor or person
Institute
Fukujuji Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Fukujuji Hospital
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo
Tel
042-491-4111
shom@fukujuji.org
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
複十字病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39889463/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39889463/
Number of participants that the trial has enrolled
233
Results
The median age of 233 participants was 65 years.Multivariate logistic regression analysis indicated a significant association between poor sleep quality, female sex, and low health-related quality of life.
Results date posted
| 2025 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 65 years, 205/233 were female, median PSQI was 6 points, 123/233 had a PSQI of >5.
Participant flow
Thisstudy was conducted at the Fukujuji Hospital, Japan Anti-Tuberculosis Association, Tokyo, Japan.
Patients were diagnosed at the Respiratory Disease Center of Fukujuji Hospital, according to clinical practice guideline criteria for the diagnosis of NTM-PD, a scheduled hospitalization for the treatment of NTM-PD from June 2017 to May 2022, and prescribed pulmonary rehabilitation.
Adverse events
None. (Not an intervention study)
Outcome measures
Subjective Sleep Quality
Health-related quality of life
Anxiety and depression
Respiratory symptoms
Pulmonary function, blood tests, sputum test findings
Exercise capacity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate subjective sleep quality in 233 patients with and to examine the prevalence and characteristics of sleep disturbances and their association with health-related quality of life in patients with non-tuberculous mycobacterial pulmonary disease.
Management information
Registered date
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060158
