Tokyo, July 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062183) titled 'Evaluation of the Effectiveness of Lifestyle Improvement Support to Sleep Quality Based on Sleep Sensor Data in Community Pharmacies' on July 14.

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 - Develop a simple and highly effective "sleep hygiene guidance" program that can be implemented in community pharmacies, and use sleep sensor data to verify its effectiveness. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Lifestyle improvement support based on sleep hygiene and health behavioral science 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 on medication for insomnia. 2) Patients age 18 years and older. 3) Patients who are able to use the non-wearable sleep sensor continuously 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) Other patients who are deemed by the principal investigator to be inappropriate to participate in the study. Target Size - 70

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 03 Month 01 Day Date of IRB - 2023 Year 03 Month 18 Day Anticipated trial start date - 2024 Year 10 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=R000063235

Disclaimer: Curated by HT Syndication.