Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Patients with Sleep Apnea Syndrome and Insomnia

Comparative Real World Effectiveness and Safety of Vornorexant and Lemborexant in Patients With COMISA: A Prospective Study - Comparative Real World Effectiveness and Safety of Vornorexant and Lemborexant in Patients With COMISA: A Prospective Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061049

Enrollment

Registered

2026-03-25

Start date

2026-03-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Athens Insomnia Scale (104 weeks after drug administration)	—

Secondary

Measure	Time frame
CPAP data (CPAP pressure (average pressure, maximum pressure), CPAP treatment adherence, disconnection rate, AHI, spO2, etc.) SleepSign-Act Ver.2.0 (MTN-220, Kissei Comtec) sleep indices, morning alertness (Activity levels within one hour after waking, one hour after waking, one to two hours, and three to four hours), and daytime activity indices (daytime calorie expenditure, etc.) (at each evaluation point) Sleep indicators including sleep depth from Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.) Evaluation of each piece of information obtained during routine clinical practice (at each evaluation point) Athens Insomnia Scale achievement rate, subgroup analysis based on CPAP adherence Improvement in subjective-objective discrepancy Ratio of medication dose increase, maintenance, and reduction	—

Measure

Time frame

CPAP data (CPAP pressure (average pressure, maximum pressure), CPAP treatment adherence, disconnection rate, AHI, spO2, etc.) SleepSign-Act Ver.2.0 (MTN-220, Kissei Comtec) sleep indices, morning alertness (Activity levels within one hour after waking, one hour after waking, one to two hours, and three to four hours), and daytime activity indices (daytime calorie expenditure, etc.) (at each evaluation point) Sleep indicators including sleep depth from Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.) Evaluation of each piece of information obtained during routine clinical practice (at each evaluation point) Athens Insomnia Scale achievement rate, subgroup analysis based on CPAP adherence Improvement in subjective-objective discrepancy Ratio of medication dose increase, maintenance, and reduction

—

Countries

Japan

Contacts

Public ContactRyutaro Shirahama

RESM Shin-Yokohama respiratory and sleep medical-care clinic Internal Medicine

shirahama.r@resm.info045-475-5155

Outcome results