UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058211 |
|---|---|
| Receipt number | R000066553 |
| Scientific Title | A study to elucidate the effects of sleep pattern modulation on emotional and nociceptive sensitivity |
| Date of disclosure of the study information | 2025/06/18 |
| Last modified on | 2025/06/18 16:15:33 |
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Basic information
Public title
A study to elucidate the effects of sleep pattern modulation on emotional and nociceptive sensitivity
Acronym
A study to elucidate the effects of sleep pattern modulation on emotional and nociceptive sensitivity
Scientific Title
A study to elucidate the effects of sleep pattern modulation on emotional and nociceptive sensitivity
Scientific Title:Acronym
A study to elucidate the effects of sleep pattern modulation on emotional and nociceptive sensitivity
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine how sleep pattern alterations associated with nocturnal awakenings affect emotional and nociceptive sensitivity in adults.
Basic objectives2
Others
Basic objectives -Others
This study will examine differences in emotional and nociceptive sensitivity in the same participants under two conditions: normal nighttime sleep versus nighttime sleep with nocturnal awakenings.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity using a visual analogue scale
Key secondary outcomes
Salivary immunoglobulin A and substance P levels
Emotional assessment using the Profile of Mood States-Brief Form (POMS-Brief)
Anxiety assessment using the State-Trait Anxiety Inventory-Form (STAI)
Sleep assessment using the OSA Sleep Inventory MA version
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Nocturnal awakenings (1day)
Interventions/Control_2
Normal nocturnal sleep (control)
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Individuals who fully understand the research content and provide both verbal and written informed consent
2) Healthy adult women aged 20-29 years
3) Individuals with no existing pain conditions (acute or chronic pain)
4) Non-smokers
5) Individuals who habitually obtain 6 or more hours of nighttime sleep
6) Individuals who have not engaged in vigorous exercise on the day before or day of the study
7) Individuals with no past medical history or current conditions involving autonomic nervous system disorders, cardiovascular diseases, central or peripheral nervous system disorders, sensory abnormalities, or dermatological conditions, and who have not been diagnosed with sleep disorders
8) Individuals who have not undergone any pharmacological interventions (oral, topical, or injectable medications) including analgesics or central nervous system-acting drugs for three days prior to study commencement
9) Individuals within one week of their last menstrual period
Key exclusion criteria
1) Individuals presenting with findings deemed to represent obvious abnormalities immediately before or during the research study
2) Individuals whom the principal investigator determines cannot maintain psychological stability or are at risk of psychological instability
3) Individuals with trauma, dermatological abnormalities, or physical abnormalities at the time of study implementation
4) Individuals taking analgesics or central nervous system-acting medications
5) Individuals whom the principal investigator determines would have difficulty completing the research or are at risk of research completion difficulties for any other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kakeda |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki city, Kanagawa
TEL
044-587-3520
kakeda-t@kawasaki-cn.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kakeda |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki city, Kanagawa
TEL
044-587-3520
Homepage URL
kakeda-t@kawasaki-cn.ac.jp
Sponsor or person
Institute
Kawasaki City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee in Kawasaki City College of Nursing
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki city, Kanagawa
Tel
044-587-3500
ethics@kawasaki-cn.ac.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 | 06 | Month | 18 | 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 | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2026 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066553
