UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059527 |
|---|---|
| Receipt number | R000067895 |
| Scientific Title | Examination of the effects of sleep fragmentation on autonomic nervous system function |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/10/24 10:22:12 |
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Basic information
Public title
Examination of the effects of sleep fragmentation on autonomic nervous system function
Acronym
Fragmented sleep and Autonomic Nervous System study
Scientific Title
Examination of the effects of sleep fragmentation on autonomic nervous system function
Scientific Title:Acronym
Fragmented sleep and Autonomic Nervous System study (FANS-study)
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the effects of sleep fragmentation (repeated sleep interruptions) on autonomic nervous activity during sleep and during the daytime, as well as on attention, cognitive function, emotional function, the endocrine system, and the inflammatory response.
Basic objectives2
Others
Basic objectives -Others
To examine the effects of sleep fragmentation as distinct from sleep restriction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability
Key secondary outcomes
Other autonomic nervous system functions, as well as attention, cognitive, and emotional functions, the endocrine system, and the inflammatory response.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In Group 1, the first intervention is conducted under the sleep fragmentation condition, forced awakening approximately every hour for 3-5 minutes during nighttime sleep. An interval of at least 7 days is maintained between conditions. The second intervention is conducted under the sleep restriction condition, limiting sleep duration to 5 hours.
Interventions/Control_2
In Group 2, the first intervention is conducted under the sleep restriction condition, limiting sleep duration to 5 hours. An interval of at least 7 days is maintained between conditions. The second intervention is conducted under the sleep fragmentation condition, forced awakening approximately every hour for 3-5 minutes during nighttime sleep.
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
1)Female participants who regularly monitor their menstrual cycle and are available during the follicular phase
2)Individuals from whom written informed consent can be obtained
Key exclusion criteria
1)Individuals with conditions likely to be exacerbated by experimental stressors, including insomnia (self-reported)
2)Individuals with arrhythmia, pacemaker implantation, or heart disease
3)Individuals taking medications that affect the autonomic nervous system function (such as beta-blockers, antidepressants, or steroids)
4)Individuals taking sleeping pills or other medications that affect sleep
5)Individuals deemed unsuitable at the discretion of the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nagao |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-346-2014
Homepage URL
knagao@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
Tel
042-341-2711
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
| 2025 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067895
