Tokyo, Dec. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059976) titled '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' on Dec. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Attention-Deficit/Hyperactivity Disorder
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 68
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 18 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2026 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068604
Disclaimer: Curated by HT Syndication.
