UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056118 |
|---|---|
| Receipt number | R000063206 |
| Scientific Title | Nocturnal sleep and childcare sharing among fathers and mothers during nursing period |
| Date of disclosure of the study information | 2024/11/11 |
| Last modified on | 2024/11/11 12:55:29 |
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Basic information
Public title
Nocturnal sleep and childcare sharing among fathers and mothers during nursing period
Acronym
Nocturnal sleep and childcare sharing among fathers and mothers during nursing period
Scientific Title
Nocturnal sleep and childcare sharing among fathers and mothers during nursing period
Scientific Title:Acronym
Nocturnal sleep and childcare sharing among fathers and mothers during nursing period
Region
| Japan |
Condition
Condition
Fathers and nursing mothers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to examine the relationship between the quality of sleep in fathers and mothers and their degree of participation in childcare, and to suggest some strategies to reduce sleep deprivation during childcare and how childcare should be shared.
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between the quality of sleep and the degree of childcare in fathers and mothers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG of sleep for three days
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Fathers and mothers with 2-6-month-olds infant
Key exclusion criteria
1) Has Mental disorder or sleep disorder.
2) Have skin problems or sensitive skin that may cause skin problems at the site of electrode application.
3) Has symptoms of alcohol sensitivity, such as skin rash caused by alcohol.
4) Their baby's weighs less than 2,500 grams at birth, or is under 37 weeks of gestation.
5) Has plans to stay overnight outside the home (business trip, travel, return home, or return to the home town) during the study period.
6) The couple is not involved in childcare during the daytime due to full-time work or other commitments.
7) Sleeps in the same bed or on the same futon as their baby.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Osugi |
Organization
Pigeon Corporation
Division name
Research & Development Div.
Zip code
300-2495
Address
6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki, Japan
TEL
0297-52-6532
yoshimi.oosugi@pigeon.com
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Osugi |
Organization
Pigeon Corporation
Division name
Research & Development Div.
Zip code
300-2495
Address
6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki, Japan
TEL
0297-52-6532
Homepage URL
yoshimi.oosugi@pigeon.com
Sponsor or person
Institute
Pigeon Corporation
Institute
Department
Personal name
Funding Source
Organization
Pigeon Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
S'UIMIN Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F, Kairaku Building, 2-7-5, Higashiueno, Taito-ku, Tokyo, Japan
Tel
03-6240-1162
jimukyoku@tes-h.co.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 | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063206
