UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055136 |
|---|---|
| Receipt number | R000062989 |
| Scientific Title | Relationship between sleep-related pathological indices and comorbid conditions in obstructive sleep apnea |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/08/01 16:21:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between sleep-related pathological indices and comorbid conditions in obstructive sleep apnea
Acronym
Relationship between sleep and comorbidities in obstructive sleep apnea
Scientific Title
Relationship between sleep-related pathological indices and comorbid conditions in obstructive sleep apnea
Scientific Title:Acronym
Relationship between sleep and comorbidities in obstructive sleep apnea
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how the severity of obstructive sleep apnea (OSA) relates to the severity of various sleep disorders from a cross-disease perspective.
This will not only reconfirm the importance of OSA treatment, but also contribute to the development of therapeutic significance and intervention techniques for comorbid sleep disorders. Furthermore, by providing new insights into the pathophysiological interrelationships between insomnia, sleep paralysis, sleep-related movement disorders, hypersomnia, and other comorbid sleep disorders, we will contribute to the understanding of the pathophysiology of these sleep disorders.
Basic objectives2
Others
Basic objectives -Others
Investigation of sleep-related pathological indicators
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Apnea Hypopnea Index (AHI)
3% Oxygen Desaturation Index (ODI)
Key secondary outcomes
Self-administered questionnaire score (insomnia/hypersomnia/depression/anxiety/quality of life), polysomnography-related variables
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals whose laboratory data obtained after January 2013 are registered in the "Polysomnography databank for sleep disorders".
Key exclusion criteria
Individuals with no primary outcome measured
Target sample size
26300
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8553, Japan
TEL
042-346-2014
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Kawamura |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8553, Japan
TEL
042-346-2014
Homepage URL
a-kawamura@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Kenichi Kuriyama
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8553, Japan
Tel
0423412712
rinri-jimu@ncnp.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study: Cross-sectional study validating a data set of polysomnography test data at a single time point
Management information
Registered date
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062989
