UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063290 |
|---|---|
| Receipt number | R000072443 |
| Scientific Title | Evaluation of the Effects of Yoga Nidra on Sleep Improvement Using Mobile Health |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/15 11:46:45 |
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Basic information
Public title
Study of Yoga Nidra for Improving Sleep
Acronym
Yoga Nidra Sleep Study
Scientific Title
Evaluation of the Effects of Yoga Nidra on Sleep Improvement Using Mobile Health
Scientific Title:Acronym
Yoga Nidra Sleep Study
Region
| Japan |
Condition
Condition
Poor sleep quality in adults aged 60 years and older
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of Yoga Nidra delivered through online sessions and audio-guided home practice on sleep in adults aged 60 years and older with sleep problems, using a randomized controlled trial. The Pittsburgh Sleep Quality Index (PSQI) will serve as the primary outcome measure. Objective sleep measures obtained from smartwatches and questionnaire-based measures of insomnia, perceived stress, and mindfulness will also be assessed. The persistence and reproducibility of the intervention effects and associations between subjective assessments and objective measures will also be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the between-group difference in the change in Pittsburgh Sleep Quality Index (PSQI) global score from before to the end of the intervention, comparing Group A, which receives Yoga Nidra first, with the wait-list control group (Group B). A 1-week baseline observation period is followed by a 4-week Yoga Nidra intervention for Group A and a further 1-week observation period beginning at the end of the intervention. Both groups complete the PSQI within 3 days of the start of each observation period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group A: Participants receive five weekly online Yoga Nidra sessions, each lasting approximately 1 hour. The first session takes place on the first day of the 4-week intervention period, and the fifth session takes place on the first day of the subsequent 1-week observation period. From the day after the first session, participants are encouraged to practice Yoga Nidra using an audio guide for approximately 30 minutes per session on days without an online session.
Interventions/Control_2
Group B (wait-list control group): Participants maintain their usual lifestyle during the intervention period for Group A. They subsequently receive the same Yoga Nidra intervention as Group A.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 60 years or older who have no difficulties in daily living.
Key exclusion criteria
1. Individuals assessed as having no sleep problems based on the RU-SATED questionnaire completed at application.
2. Individuals receiving treatment for insomnia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Niida |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Laboratory of Molecular Medicine
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL
03-5449-5237
aniida@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Niida |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Laboratory of Molecular Medicine
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL
03-5449-5237
Homepage URL
aniida@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
CAREER CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Observational Studies, The Institute of Medical Science, The University of Tokyo
Address
3F, Building 1, 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
Tel
03-6409-2035
ken-rin@ims.u-tokyo.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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2027 | 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 | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072443
