Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062184) titled 'Evaluation of the Effectiveness of Sleep Quality Improvement through Lifestyle Improvement Support at Community Pharmacies Using Sleep Digital Biomarkers' on July 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Wakayama Medical University

Condition: Condition - Sleep Disorder, Insomnia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine the effect of improving sleep quality by providing lifestyle modification support based on sleep hygiene and health behavioral science by pharmacists in community pharmacies for persons with insomnia, using digital biomarkers. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Sleep hygiene and behavior science skills by pharmacists in community pharmacies. Interventions/Control_2 - Usual care

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients undergoing sleep treatment with medications. 2) Patients age 18 years and older. 3) Patients who can use a sleep device during the study period. Key exclusion criteria - 1) Patients with prescriptions for psychiatric or anti-dementia medications. 2) Patients who have difficulty participating in the study on a continuous basis (approximately 3 months). 3) Patients who are employed in shift work 4) Patients who are judged by the principal investigator to be inappropriate as research participants. Target Size - 70

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 03 Month 01 Day Date of IRB - 2023 Year 03 Month 18 Day Anticipated trial start date - 2024 Year 03 Month 01 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063233

Disclaimer: Curated by HT Syndication.