NCT06093126 Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
| NCT ID | NCT06093126 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nova Scotia Health Authority |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 1 participants |
| Start Date | 2023-12-11 |
| Primary Completion | 2028-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1 participants in total. It began in 2023-12-11 with a primary completion date of 2028-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Insomnia is a highly common, chronic disorder that is distressful for the patient but also for caregivers and can give rise to a heavy burden on the healthcare team. Sleeping aids like benzodiazepines and other sedatives (e.g., zolpidem, zopiclone) have been widely used to help treat insomnia. However, sleeping aids are also known to cause adverse drug reactions such as drowsiness and dizziness, that increases the risk of falls, driving impairment, visual impairment, cognitive impairment, and upon discontinuation may cause paradoxical rebound insomnia, delirium, and nightmares all of which exacerbate the initial insomnia. All of the negative aspects of sleeping aid use are exaggerated for older, frail adults. Some patients experience an early (young-age) onset dementia with a substantial component of insomnia. Due to the many risks associated with traditional sleeping aids they are often inappropriate in adults living with cognitive impairment and/or frailty. Lemborexant comes from a new class of medications for insomnia. Lemborexant is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors orexin 1 receptor (OX1R) and orexin 2 receptor (OX2R), which is thought to suppress wake drive. Unlike other traditional sleeping aids, lemborexant has not shown to be significantly associated with driving impairment, rebound insomnia, or dependence/withdrawal symptoms. Also, in clinical trials it only rarely causes the types of adverse events associated with benzodiazepines and other traditional sedatives and is less often associated with discontinuations due to adverse events. While lemborexant is available on the Canadian market it is unclear how this medication will be tolerated by patients living with an early onset dementia. Understanding the effectiveness and tolerability of lemborexant will be helpful in an N of 1 trial to understand the details of effect and effectiveness in individual patients.
Eligibility Criteria
Inclusion Criteria: * Identified by clinician investigator to have early-onset dementia and a significant component of insomnia. Exclusion Criteria: * Known sleep disorders that are contraindications for orexin antagonist therapy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06093126 clinical trial?
This trial is open to participants of all sexes, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06093126 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06093126 currently recruiting?
Yes, NCT06093126 is actively recruiting participants. Contact the research team at shanna.trenaman@dal.ca for enrollment information.
Where is the NCT06093126 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT06093126 clinical trial?
NCT06093126 is sponsored by Nova Scotia Health Authority. The trial plans to enroll 1 participants.
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