UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061048 |
|---|---|
| Receipt number | R000069374 |
| Scientific Title | Real World Efficacy and Safety of Vornorexant versus Lemborexant in Patients with Insomnia: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/25 14:06:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Insomnia
Acronym
Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Insomnia
Scientific Title
Real World Efficacy and Safety of Vornorexant versus Lemborexant in Patients with Insomnia: A Prospective Observational Study
Scientific Title:Acronym
Real World Efficacy and Safety of Vornorexant versus Lemborexant in Patients with Insomnia: A Prospective Observational Study
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate changes in sleep-related parameters (such as subjective and objective sleep assessment scores) following administration of Vornorexant (Vorzzz) or lemborexant (Dayvigo) in patients with insomnia excluding sleep apnea syndrome, and to assess their efficacy and safety in a real-world clinical setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep Log (52 weeks after drug administration)
Subjective sleep latency
Key secondary outcomes
Sleep Diary (Week 52 after drug administration)
Subjective WASO (Wake After Sleep Onset), total sleep time, sleep efficiency
Athens Insomnia Scale (Week 52 after drug administration)
Sleep indices from the Kissei Activity Monitor (SleepSign-Act Ver.2.0, FS-770), morning alertness (activity levels from wake-up to 1 hour, from 1 to 2 hours, and from 3 to 4 hours after waking), and daytime activity indices (e.g., daytime calorie expenditure) (at each evaluation point)
Sleep depth and other sleep indicators obtained from Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.)
Information obtained during routine medical care (heart rate, sleep diary, Athens Insomnia Scale, Karolinska Sleepiness Scale (KSS), Pittsburgh Sleep Quality Index (PSQI), Restorative Sleep Questionnaire (RSQ) Japanese version, etc.), medication safety, hyperarousal assessment (Hyperarousal Scale Japanese version (HAS-J), Japanese version of the Pre-Sleep Arousal Scale (PSAS), etc.), Ford Insomnia Response to Stress Test (FIRST), Japanese version of the Insomnia Catastrophizing Scale (ICS), dysfunctional beliefs and attitudes about sleep (DBAS), Montreal Cognitive Assessment (MoCA), Kissei activity monitor (SleepSign-Act Ver.2.0, FS-770), Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.) sleep indices and daytime activity indices) (at each assessment point), side effects and safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 less than 10 events per hour based on overnight polysomnography (PSG) testing
2)Individuals diagnosed with insomnia according to the ICSD-3 diagnostic criteria
3)Individuals who consent to administration of Vornorexant (Vorzzz) (*)
4) Individuals who consent 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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryutaro |
| Middle name | |
| Last name | Shirahama |
Organization
RESM Shin-Yokohama respiratory and sleep medical-care clinic
Division name
Internal Medicine
Zip code
222-0033
Address
3-8-12, Sinyokohama, kouhoku-ku, Yokohama, Japan
TEL
045-475-5155
shirahama.r@resm.info
Public contact
Name of contact person
| 1st name | Ryutaro |
| Middle name | |
| Last name | Shirahama |
Organization
RESM Shin-Yokohama respiratory and sleep medical-care clinic
Division name
Internal Medicine
Zip code
222-0033
Address
3-8-12, Sinyokohama, kouhoku-ku, Yokohama, Japan
TEL
045-475-5155
Homepage URL
shirahama.r@resm.info
Sponsor or person
Institute
RESM Shin-Yokohama respiratory and sleep medical-care clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
RESM Medical Corporation Ethics Review Committee
Address
3-8-12, Sinyokohama, kouhoku-ku, Yokohama, Japan
Tel
045-475-5155
support@resm.info
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 | 04 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Prospective Observational Study (Cohort)
Factors to Examine for Association (Exposure):
Type of administered drug: Vornorexant (Vorzzz) or Lemborexant (Dayvigo)
Covariates collected and adjusted for in analyses include: presence of concomitant medications, underlying medical conditions, age, gender, BMI, medical history, and receipt of sleep hygiene instruction.
Method: Consecutive cases from outpatient clinics at the facilities (RESM Shin-Yokohama, Shin-Tokyo) will be enrolled.
Bias Reduction and Statistical Plan (Summary): For background factor imbalances, we will consider multivariate regression and cut-off sensitivity analysis (e.g., multiple substitutions).
Management information
Registered date
| 2026 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069374
