Tokyo, March 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061049) titled 'Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Patients with Sleep Apnea Syndrome and Insomnia' on March 25.
Study Type:
Observational
Primary Sponsor:
Institute - RESM Shin-Yokohama respiratory and sleep medical-care clinic
Condition:
Condition - insomnia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to prospectively evaluate the effects of vornorexant or lemborexant administration on sleep-related parameters (subjective and objective sleep assessment scores), daytime functioning, and impact on CPAP therapy in COMISA patients, thereby comparing the efficacy and safety of both drugs in a real-world clinical setting.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients with an AHI of 20 or more events per hour based on overnight polysomnography (PSG) testing
2)Individuals diagnosed with insomnia according to the ICSD-3 diagnostic criteria
3)Individuals who consented to administration of Vornorexant (Vorzzz) (*)
4) Individuals who consented to administration of Lemborexant (Dayvigo) (*)
5) Patients deemed necessary by the outpatient physician
*; Only one medication will be prescribed.
Key exclusion criteria - Patients unwilling to participate in this study
Patients unwilling to undergo PSG testing
Severe hepatic impairment (Child-Pugh class C)
History of hypersensitivity to any component of Vornorexant (Vorzzz)
History of hypersensitivity to any component of Lemborexant(Dayvigo)
Pregnant or breastfeeding women
Individuals unable to complete questionnaires due to cognitive impairment or other reasons
Other patients deemed unsuitable for the study by the principal investigator
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 04 Day
Date of IRB - 2026 Year 02 Month 04 Day
Anticipated trial start date - 2026 Year 03 Month 03 Day
Last follow-up date - 2032 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069572
Disclaimer: Curated by HT Syndication.
