UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054626 |
|---|---|
| Receipt number | R000062423 |
| Scientific Title | Exploration of the relationship between central nervous system pathology and clinical and psychological symptoms in chronic insomnia disorder with coexistent obstructive sleep apnea. |
| Date of disclosure of the study information | 2024/06/15 |
| Last modified on | 2024/06/11 14:16:14 |
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Basic information
Public title
Exploration of the relationship between brain pathology and clinical and psychological symptoms in chronic insomnia disorder with coexistent obstructive sleep apnea.
Acronym
The relationship between brain pathology and clinical and psychological symptoms in COMISA
Scientific Title
Exploration of the relationship between central nervous system pathology and clinical and psychological symptoms in chronic insomnia disorder with coexistent obstructive sleep apnea.
Scientific Title:Acronym
The relationship between central nervous system pathology and clinical and psychological symptoms in COMISA
Region
| Japan |
Condition
Condition
Chronic insomnia disorder,
obstructive sleep apnea,
co-morbid insomnia and sleep apnea
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between central nervous system pathology and clinical symptoms (psychological and physiological pathology) in patients with co-morbid insomnia and sleep apnea, compared with chronic insomnia disorder or obstructive sleep apnea alone.
Basic objectives2
Others
Basic objectives -Others
Evaluation of central nervous system pathology
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
MRI brain images
Key secondary outcomes
sleep diaries, polysomnographic sleep variables and sleep stage variables, self-administered questionnaires (insomnia severity, hypersomnia/hyperarousal severity, depression severity, anxiety-related symptoms severity, disability severity, cognitive impairment severity)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic insomnia disorder, obstructive sleep apnea, or co-morbid insomnia and sleep apnea who are visiting our Sleep Disorders Center.
Key exclusion criteria
Nothing
Target sample size
165
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
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Utsumi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
Homepage URL
https://www.ncnp.go.jp/hospital/partnership/ethics_result.html
t-utsumi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
nothing
Name of secondary funder(s)
nothing
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2712
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
国立精神神経医療研究センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 15 | 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 | 11 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study Design: Case-Control Study
Participant Recruitment Method: Participants were recruited from among patients who visited our sleep clinic and underwent MRI examination between April 1, 2020, and September 30, 2023.
Evaluation Items: MRI brain images, sleep diaries, polysomnographic sleep variables and sleep stage variables, self-administered questionnaires (insomnia severity, hypersomnia/hyperarousal severity, depression severity, anxiety-related symptoms severity, disability severity, cognitive impairment severity)
Management information
Registered date
| 2024 | Year | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062423
