Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062456) titled 'Do bedtime sounds work differently from person to person? A study in which each participant tries and compares several sounds' on Aug. 3.

Study Type: Interventional

Study Design: Basic Design - n-of-1 Randomization - Randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Healthy adults with mild or greater insomnia symptoms (ISI-J score of 8 or more) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To characterize inter-individual variability in sleep responsiveness to bedtime auditory interventions (pink noise, nature sounds, slow-tempo instrumental music, and silence) in healthy adults with mild sleep difficulty, using a within-person repeated-measures (N-of-1) design; and to develop a machine-learning model that predicts the optimal auditory condition for each individual from personal characteristics (personality traits, noise sensitivity, chronotype, and sleep profile), testing whether its predictive accuracy significantly exceeds the four-condition chance level of 25%. As a secondary aim, mediation analysis will decompose the pathway from the auditory intervention through shortened sleep onset latency to next-morning daytime function. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Pink noise: 1/f noise with emphasized low frequencies, played automatically from bedtime until 30 minutes after sleep onset. Interventions/Control_2 - Nature sounds: rain and ocean waves, delivered in the same way as Arm 1.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - (1) Adults aged 18 to 75 years.

(2) Able to understand Japanese and to complete the questionnaires.

(3) Own a smartphone running iOS 16 or later, or Android 10 or later.

(4) A total score of 8 points or more on the Japanese version of the Insomnia Severity Index (ISI-J; Bastien et al., 2001), indicating at least mild insomnia.

(5) Willing to wear the wearable device loaned by the study team (wristband, watch, or upper-arm band type) every night and to listen to the assigned sound throughout the approximately four-week study period.

(6) Willing to complete the Consensus Sleep Diary and a 3-minute psychomotor vigilance task (PVT-3min) every morning, taking about six minutes in total, during the study period.

(7) Able to provide written informed consent, including electronic consent.

(8) No restriction on the area of residence. Key exclusion criteria - (1) Diagnosed by a physician with a sleep disorder such as sleep apnea syndrome or restless legs syndrome.

(2) Currently taking hypnotics or psychotropic medication on a regular basis.

(3) Severe hearing impairment.

(4) Engaged in shift work, including night shifts, within the past month.

(5) Travelled across two or more time zones within the past month.

(6) Serious physical or psychiatric illness.

(7) Pregnant or possibly pregnant.

(8) Judged unsuitable for participation by the investigators for any other reason. Target Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 25 Day Date of IRB - 2026 Year 06 Month 25 Day Anticipated trial start date - 2026 Year 08 Month 03 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071479

Disclaimer: Curated by HT Syndication.