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NOT YET RECRUITING
NCT07840638
PHASE4

How Well and Safely Does Lemborexant Work for People Who Wake up at Night to Urinate (LENS)

Sponsor: University of Alberta

View on ClinicalTrials.gov

Summary

Nocturia is defined by doctors as getting up one or more times a night to use the bathroom, where you were asleep before going to use the washroom and then going back to sleep afterward. People who experience this condition describe it was one of their biggest problems. This condition is very common as people get older and can seriously affect older peoples quality of life including disruptions to sleep, daily functioning, risk of falls and even early death.

Official title: The LENS Study: Efficacy and Safety of Lemborexant for Patients With Nocturia

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2026-10-15

Completion Date

2030-07-20

Last Updated

2026-09-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Lemborexant tablets

5mg (one tablet) orally at bedtime for weeks 1-3, with optional uptitration to 10mg (two tablets) for weeks 4-6.

DRUG

Placebo

Matching placebo tablet, one at bedtime weeks 1-3, optionally two for weeks 4-6 to preserve masking

Locations (1)

Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp Edmonton

Edmonton, Alberta, Canada