UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059976 |
|---|---|
| Receipt number | R000068604 |
| Scientific Title | Evaluation of the Effects of a Sensory Room on Vagal Activity and Attention Function in Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/04 16:59:43 |
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Basic information
Public title
Evaluation of the Effects of a Sensory Room on Vagal Activity and Attention Function in Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized Crossover Trial
Acronym
A Study on the Effects of a Relaxation Room in Adults with Attention-Deficit/Hyperactivity Disorder
Scientific Title
Evaluation of the Effects of a Sensory Room on Vagal Activity and Attention Function in Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized Crossover Trial
Scientific Title:Acronym
Evaluation of the Effects of a Sensory Room in Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized Crossover Trial
Region
| Japan |
Condition
Condition
Attention-Deficit/Hyperactivity Disorder
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of Sensory room use on vagal activity in adults with ADHD, in comparison with an intervention using healing music alone. Additionally, we will compare the effects on attention function, cerebral blood flow in related regions, time perception, subjective mood state, and interoceptive awareness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Resting Respiratory Sinus Arrhythmia (RSA) before and after the intervention
Key secondary outcomes
[The following items before and after the intervention]
(a) Changes in RSA in response to sensory stimulation (difference between sensory stimulation and resting baseline)
(b) Reaction time and commission errors in the Go/No-Go task
(c) Changes in cerebral blood flow during the Go/No-Go task
(d) Reproduction error in the time reproduction task
(e) Scores on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
(f) Scores on the Profile of Mood States, 2nd Edition (POMS2)
(g) Scores on the State-Trait Anxiety Inventory (STAI)
[The following items during the intervention]
(a) RSA (at the start, at 10 minutes, at 20 minutes, and at the end)
[Other background information of participants]
(a) Basic demographic characteristics
(b) Medical information
(c) Scores on the Autism-Spectrum Quotient (AQ)
(d) Scores on the Conners' Adult ADHD Rating Scales (CAARS)
(e) Scores on the Adolescent/Adult Sensory Profile (A/ASP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
[Intervention using the Sensory room]
A Sensory room measuring approximately 5.0 m^2 x 2.0 m was constructed in the Human Health Sciences at Kyoto University. One participant and one occupational therapist or occupational therapy student (research implementer) enter the room. The room contains a bubble tube, a music player with healing-music tracks, a weighted blanket, a reclining chair, an aroma diffuser with essential oils, and tactile balls.
Participants spend time seated in the reclining chair under lights-off conditions, with the weighted blanket, while the bubble tube, healing music, and aroma are provided. Each intervention session lasts 30 minutes.
Interventions/Control_2
[Intervention using healing-music]
One participant and one occupational therapist or occupational therapy student enter the same room used for the Sensory room intervention. Under lights-off conditions, the participant listens to healing-music tracks played on the music player while seated in the reclining chair. The healing-music tracks and the recline angle of the chair are identical to those used in the Sensory room intervention. Each session lasts 30 minutes.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) Age between 18 and 65 years at the time of enrollment.
(b) Diagnosed with Attention-Deficit/Hyperactivity Disorder according to DSM-5 criteria.
(c) No planned change in primary medication during the intervention period.
(d) A total score of >=1 on the Japanese Sensory Inventory mini (JSI-mini).
Key exclusion criteria
(a) Presence of cardiac complications.
(b) Use of a cardiac pacemaker.
(c) Organic or functional impairment of vision, hearing, touch, smell, or taste.
(d) Strong resistance or fear toward enclosed or dark spaces.
(e) Potential adverse physical or psychological reactions to essential oils.
(f) Risk of harm to others or self-injury.
(g) Anticipated inability to complete the study period due to hospitalization, relocation, etc.
(h) Determination by the treating physician that participation would be difficult.
(i) Any history of visual, auditory, language comprehension, psychiatric, or motor impairments expected to interfere with participation in the study tasks.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Clinical Cognitive Neuroscience, Advanced Occupational Therapy, Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3968
irie.keisuke.8n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Irie |
Organization
Kyoto University
Division name
Clinical Cognitive Neuroscience, Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3968
Homepage URL
irie.keisuke.8n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Mannari Hospital Medical Corporation, Magobei Kobayashi Memorial Medical Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学大学院（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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 | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068604
