UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061049 |
|---|---|
| Receipt number | R000069572 |
| Scientific Title | Comparative Real World Effectiveness and Safety of Vornorexant and Lemborexant in Patients With COMISA: A Prospective Study |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/25 14:07:55 |
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Basic information
Public title
Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Patients with Sleep Apnea Syndrome and Insomnia
Acronym
Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Patients with Sleep Apnea Syndrome and Insomnia
Scientific Title
Comparative Real World Effectiveness and Safety of Vornorexant and Lemborexant in Patients With COMISA: A Prospective Study
Scientific Title:Acronym
Comparative Real World Effectiveness and Safety of Vornorexant and Lemborexant in Patients With COMISA: A Prospective Study
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Athens Insomnia Scale (104 weeks after drug administration)
Key secondary outcomes
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
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 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 sample size
60
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 | 03 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study evaluating the efficacy, safety, and impact on CPAP therapy of vornorexant or lemborexant in patients with insomnia who also have sleep apnea syndrome (SAS) in a real-world clinical setting. The primary endpoint is the Athens Insomnia Scale (AIS) at week 104. Secondary endpoints include CPAP device output (mean/maximum pressure, adherence, discontinuation rate, AHI, SpO2, etc.), sleep indices from SleepSign Act Ver.2.0 (MTN 220, Kissei Comtec), sleep depth indicators from Kenko Ai Ring (Kai 01, KenkoAi Co., Ltd.), and daytime function (activity level, calories expended, etc.).
Drug selection and dose adjustment are left to the attending physician's standard clinical judgment; no study-specific interventions are performed. CPAP data and wearable/actigraphy data are secondary uses of information obtained during standard care (no additional invasive tests).
Primary analyses will include pre-specified comparisons and sensitivity analyses adjusting for covariates (age, sex, baseline SAS severity, baseline AIS, etc.). Subgroup analyses will be conducted by CPAP adherence, AIS achievement rate, and presence/absence of subjective-objective discrepancy.
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=R000069572
