Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNova Scotia Health Authority
About this trial
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
This trial does not accept healthy volunteersQualifiers
Identified by clinician investigator to have early-onset dementia and a significant component of insomnia.
Disqualifiers
Known sleep disorders that are contraindications for orexin antagonist therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Lemborexant 5 MG
DrugThe participant will receive 8 weeks of treatment Week 1 = placebo Week 2 = lemborexant 5mg Week 3 = lemborexant 10 mg Week 4 = placebo Week 5 = lemborexant 10 mg Week 6 = placebo Week 7 = placebo Week 8 = lemborexant 10 mg
Treatment groups
1 Participants
are divided into 1 treatment groupGroup A: lemborexantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total sleep time
Total number of hours of sleep
Time frame
Daily for 8 weeks2
Sleep onset latency (SOL)
How long it takes to fall asleep the first time the patient goes to sleep in minutes
Time frame
Daily for 8 weeks3
Wake time after sleep onset
How long the patient is awake overnight
Time frame
Daily for 8 weeks4
Number of night awakenings
How many times the patient wakes overnight
Time frame
Daily for 8 weeksSecondary outcomes
1
Presence & severity of ADRs
Monitor events that may be related to medication use
Time frame
Daily for 8 weeks2
Drop-out due to ADR
Monitor events that may be related to medication use
Time frame
Daily for 8 weeksSponsors and contacts
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Source ClinicalTrials.gov