UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000060245
Receipt number R000068908
Scientific Title Effects of the Interval between Task Acquisition and Sleep Onset on Motor Learning Retention
Date of disclosure of the study information 2026/01/02
Last modified on 2026/01/02 21:03:46

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Basic information

Public title

Effects of the interval between task acquisition and sleep onset and bedtime on motor skill retention

Acronym

Effects of the interval between task acquisition and sleep onset and bedtime on motor skill retention

Scientific Title

Effects of the Interval between Task Acquisition and Sleep Onset on Motor Learning Retention

Scientific Title:Acronym

Effects of the Interval between Task Acquisition and Sleep Onset on Motor Learning Retention

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine, in healthy adults under ecologically valid sleep conditions, whether the interval between skill learning and sleep onset (6 h vs 8 h) and bedtime (22:00 vs 00:00) influence motor skill retention on the next day and one week later.

Basic objectives2

Others

Basic objectives -Others

motor skill retention

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Motor skill retention rate on day 2: retention rate (%) calculated from day-2 performance (RMSE) relative to the day-1 post-test

Key secondary outcomes

1) Motor skill retention rate on day 7
2) Actigraphy-derived sleep parameters over 2 weeks (bedtime, wake-up time, TRT, TST, REM, non-REM, WASO, sleep efficiency)
3) Subjective sleep measures (PSQI-J, JESS)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

YES

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

G1: 6h learning to sleep interval. Sleep 22:00 to 05:00 (7h).
Day 1: pinch force tracking task, 15 blocks (pre 1 + training 13 + post 1).
Days 2 and 7: retention test, 1 block each. Sleep monitored by actigraphy for 2 weeks.

Interventions/Control_2

G2: 8h learning to sleep interval. Sleep 00:00 to 07:00 (7h). Other procedures same as G1.

Interventions/Control_3

G3 (control): 6h learning to sleep interval (same as G1) but sleep 00:00 to 07:00 (same as G2) to control for sleep onset time. Other procedures same as G1.

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

- Healthy adults aged 18 to 30 years
- No history of musculoskeletal disease and no upper limb injury within the past year
- No current or previous history of central nervous system disease, sleep disorder, or psychiatric disorder (screened by interview/questionnaires)
- Able to provide written informed consent and comply with the study procedures including sleep schedule control

Key exclusion criteria

- Not meeting the inclusion criteria
- Deemed inappropriate by the investigator (e.g., unable to wear the actigraphy device or adhere to the assigned sleep schedule)
(Discontinuation: discovery of relevant history, deviation from assigned sleep schedule confirmed by actigraphy, health problems, or withdrawal of consent)

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Tomofumi
Middle name
Last name Yamaguchi

Organization

Juntendo University

Division name

Department of Physical Therapy

Zip code

113-8421

Address

3-2-12 Hongo, Bunkyo-ku, Tokyo

TEL

03-3812-1780

Email

t.yamaguchi.ja@juntendo.ac.jp


Public contact

Name of contact person

1st name Kotaro
Middle name
Last name Kawashima

Organization

Juntendo University

Division name

Department of Physical Therapy

Zip code

113-0033

Address

3-2-12 Hongo, Bunkyo-ku, Tokyo

TEL

03-3812-1780

Homepage URL


Email

fhs8323008@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Juntendo University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

ACCELStars Co., Ltd. (in-kind support: actigraphy device provided free of charge)

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee, Faculty of Health Sciences, Juntendo University

Address

Ochanomizu Center Building, 3-2-12 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

Tel

03-3812-1780

Email

fhs8323008@juntendo.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

Juntendo University


Other administrative information

Date of disclosure of the study information

2026 Year 01 Month 02 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

39

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

Completed

Date of protocol fixation

2023 Year 07 Month 18 Day

Date of IRB

2023 Year 07 Month 18 Day

Anticipated trial start date

2023 Year 07 Month 18 Day

Last follow-up date

2025 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

2026 Year 01 Month 02 Day

Last modified on

2026 Year 01 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068908