insomnia insomnia
Conditions
Interventions
5 mg Lemborexant is orally administered immediately before going to bed for 12 weeks. The dose of Lemborexant can be adjusted according to the subject's symptoms, but the dose should not be exceeded 1
Sponsors
Norio Ozaki
Akihiro Fujimoto
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) able to provide voluntary informed concent 2) aged 50 years or older 3) meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for insomnia disorder 4) 24 or greater of MMSE-J score
Exclusion criteria
Exclusion criteria: 1) with a history of hypersensitivity to Lemborexant 2) with severe hepatic impairment (Child-Pugh classification C) 3) have previously used Lemborexant 4) take sleeping pills within 1 week before obtaining consent 5) have psychiatric disorders that may affect the tests specified in the study protocol 6) have been receiving CPAP therapy or subjects who are diagnosed following diseases by pulse oximeter or electromyogram - obstructive sleep apnea required CPAP treatment - specific sleep disorder except insomnia, such as periodic limb movement disorder or restless legs syndrome 7) have been diagnosed with narcolepsy 8) have been diagnosed with dementia 9) with the clinically significant symptoms or illnesses that affect the safety of the subject or the implementation of this study in the opinion of the investigator - cardiac disorder [subjects with repeatied QT/ QTc over 450ms at the screening (QT interval corrected by Fridericia method: QTcF)] - respiratory disorder (including chronic obstructive pulmonary disease, acute or severe respiratory disorder) - severe liver, digestive or renal (including renal dysfunction) disease - neurological or mental disorders - carcinooma (excluding appropriate treated basal cell carcinoma) withing 5 years or chronic pain 10) brestfeeding or pregnant female 11) disagree to contraception throughout the study period 12) unable to conduct MRI scan 13) unable to use gadolinium contrast media (only subjects who can perform gadolinium tracer) 14) judged to be inappropriate by the principle investigator or the subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in objective sleep parameters from baseline to week 4 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in subjective sleep parameters from baseline to week 4 and 12 2) Aassociation between improvement of objective sleep parameters and the ALPS index, at week 12 3) Aassociation between improvement of subjective sleep parameters and the ALPS index, at week 12 | — |
Contacts
Public ContactIwamoto Kunihiro
Nagoya University Hospital
Outcome results
None listed