Recruiting PHASE4 Insomnia

New treatment option for Insomnia

Official title Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial

ClinicalTrials.gov ID: NCT06093126

What this study is testing

What is Lemborexant 5 MG?

Lemborexant 5 MG is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for insomnia.

Also referred to as Lemborexant 10 MG.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Adults

You may be able to join if

  • Identified by clinician investigator to have early-onset dementia and a significant component of insomnia.

You likely can't join if

  • Known sleep disorders that are contraindications for orexin antagonist therapy.

The study team makes the final eligibility decision.

Where it's taking place

  • Halifax, Nova Scotia, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.