Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058626) titled 'The effect of sleep-improving medication administered with a food thickener on nighttime sleep patterns' on July 29.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Chiba University
Condition:
Condition - insomnia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The effect of sleep-improving drugs efficacy took with food thickener on nighttime sleep patterns was clarified through objective evaluation using non-contact sleep sensors.
Basic objectives2 - PK,PD
Intervention:
Interventions/Control_1 - Using food thickener
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. over 20 years
2. taking Driwell tablets or to be taken Driwell tablets due to temporary insomnia
Key exclusion criteria - 1. Patients who are unable to take a water using them mouse
2. Patients who using other hypnotics
3. Patients who are unable to use the sleep sensor by using sofa bed
4. Patients who are unable to make decisions for themselves
5. Patients who are allergic to the food thickener
6. Patients with irregular sleep patterns due to night shifts
7. Patients who share bedding with family or pets and whose sleep patterns cannot be observed
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 12 Day
Anticipated trial start date - 2025 Year 07 Month 29 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067039
Disclaimer: Curated by HT Syndication.
