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

September 22, 2026 updated by: University of Alberta

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nocturia, defined by the International Continence Society (ICS) as the complaint of waking up one or more times per night to void, with each void typically preceded and followed by sleep (4,5). Nocturia is not only described as one of the most bothersome of all urinary symptoms, but also as one of the most prevalent, with devastating impacts on quality of life (QOL)(5,6). Although nocturia is relatively infrequent among young adults, especially young women (compared to young men), its prevalence tends to increase with age. In individuals aged 60 years or older, reported rates can reach as high as 70%, with over 36% reporting the need to wake up 2 or more times per night to void (7). A recently published meta-analysis reported associations between nocturia and risk of falls, fractures, and early mortality (8).

The causes of nocturia are complex and multifactorial, including nocturnal polyuria (NP - defined as excessive urine production during sleep), sleep disorders (such as insomnia, sleep apnea), metabolic conditions (such as diabetes, uncontrolled hypertension), bladder dysfunctions (OAB or BPE), lifestyle factors (fluid or alcohol intake), or a combination of these conditions (7,9,10).

In Canada, the increasing proportion of older adults, projected to constitute approximately 25% of the population by 2041, poses a notable public health concern owing to the association between nocturia and aging and the potential public health costs of managing the condition (11,12). Bothersome nocturia, defined clinically as two or more nightly voids, is more than just an inconvenience. It has notable clinical implications, including impaired cognitive function during the day, fatigue, falls, depression, and a considerable decrease in health-related quality of life (HRQOL), highlighting the need for new treatment approaches.

Rationale for the study:

The results of a recent study conducted with 32 insomnia patients with nocturia who typically awoke two or more times per night to void demonstrated that 4 weeks of once-daily 5mg Lemborexant significantly improved multiple clinical parameters related to sleep quality and nocturia (13). Nocturia frequency was significantly reduced from a mean of 3.4 episodes per night to 2.3 episodes (p<0.001). Additionally, measures from the frequency-volume chart showed a significant increase in mean single voided urine volume at night from 182.5ml to 222.3 ml (p<0.001). The mean duration of undisturbed sleep also increased from 105.3 minutes to 174.8 minutes (p < 0.001), approaching the three-hour period of deep sleep vital for older adults. Participant quality of life, assessed by the Nocturia Quality of Life Questionnaire (N-QOL), significantly improved from 49.6% to 64.8% (p<0.001).

This recent study, however, was a single-arm, uncontrolled, prospective study conducted at two centers in Japan. Its key limitations include the absence of a placebo control group, relatively small sample size (n=32), and a population limited to patients with comorbid insomnia (Athens Insomnia Scale ≥6).

The present study addresses some of these methodological gaps by employing a randomized, double-blind, placebo-controlled, crossover design with bothersome nocturia confirmed using a validated bother instrument (ICIQ-N), following a standardized period of conservative treatment. Conservative treatment will consist of individualized, physician-recommended measures, including fluid intake, leg elevation, sodium restriction, medication review, and the use of mild compression stockings where relevant.

Primary Objective:

The primary objective of this study is to assess the efficacy of Lemborexant (versus placebo) in reducing nocturia episodes in older men and women (≥65) with bothersome nocturia. Efficacy will be assessed as a change in mean nocturia episodes per 24 hours, measured using a 7-night bladder diary, between baseline and the end of study (EoS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2P4
        • Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp Edmonton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥65 years
  • Has nocturia as determined by ICS criteria (ICIQ-N)
  • Has Nocturia, after 4 weeks of conservative treatment (fluid advice, leg elevation, sodium restriction, medication review, mild compression stockings where relevant), indicates a score of ≥4 on question 4b of the validated ICIQ Nocturia module [https://iciq.net/iciq-n] - (indication of bother rating of 4-10)
  • Participants with prior treatment for concomitant OAB should have been on stable doses of therapy for 12 weeks prior to inclusion.

Exclusion Criteria:

  • Participant has a 24h polyuria (>3L), measured by a 7-day bladder diary

    • Participant has a post-void residual (>250mL), measured by ultrasound following void from a comfortably full bladder
    • Participant has an acute symptomatic UTI (can be treated and rescreened for inclusion)
    • The participant has known untreated sleep apnoea, or highly likely OSA according to the validated STOP-BANG questionnaire (score 5-8)
    • The participant has significant heart failure (NYHA C/D)
    • The participant has severe renal impairment (eGFR <30mL/min), severe hepatic impairment (Child-Pugh class 3)
    • The participant is taking hypnotics
    • The participant is taking strong CYP3A inducers such as rifampin, carbamazepine, St. John's wort
    • The participant has a known drug allergy to Lemborexant or its constituents
    • The participant has cognitive impairment of a degree which, in the opinion of the investigator, is likely to impair the ability to adhere to trial requirements
    • The participant is unwilling to abstain from alcohol consumption for the period of the study
    • Other condition(s) which would preclude inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence A: Lemborexant then Placebo

Lemborexant at bedtime for 6 weeks (5 mg weeks 1-3), optional uptitration to 10 mg (weeks 4-6), and then 2 week washout, then matching placebo for 6 weeks.
Drug: Lemborexant tablets

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

Other Names:
  • Dayvigo
Experimental: Sequence B: Placebo then Lemborexant

Matching placebo at bedtime for 6 weeks (1 tablet weeks 1-3, optional increase to 2 tablets weeks 4-6), then 2 week washout, then Lemborexant for 6 weeks
Drug: Placebo

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in mean nocturia episodes per 24 hours
Time Frame: 42 Days

Change in mean nocturia episodes per 24 hours, measured by a 7-day/night bladder diary between baseline and the end of each treatment period. Participants will record the time and volume of each void (day and night) for 7 consecutive days at baseline (prior to randomization) and at week 6 (the final treatment weeks: days 35-42) of each treatment period.
42 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Epiworth Sleepiness Scale (ESS)
Time Frame: 42 days

Change in Epiworth Sleepiness Scale between baseline and EoS. The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that assesses an individual's general level of daytime sleepiness by asking respondents to rate their likelihood of dozing in eight everyday situations. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness
42 days
Change in nocturia associated quality of life
Time Frame: 42 days

Change in nocturia associated quality of life (ICIQ-NQoL) between baseline and EoS. The International Consolation on Incontinence Nocturia Quality of Life (ICIQ NQoL) is a validated, disease-specific, patient-reported outcome instrument developed to measure the impact of nocturia on health-related quality of life. The total score equals the sum of all item responses, ranging from 0 to 58, with higher values indicating a greater impact on patient quality of life.
42 days
Change in Insomnia Severity Index (ISI)
Time Frame: 42 days

Change in Insomnia Severity Index (ISI) between baseline and EoS. The Incontinence Severity Index, developed by Sandvik and colleagues, is a validated instrument that quantifies the severity of urinary incontinence based on the frequency and amount of leakage. Scores are derived by multiplying responses on two items, yielding a severity category ranging from slight to severe.
42 days
Change in mean reported first uninterrupted sleep period (FUSP)
Time Frame: 42 days

Change in mean reported first uninterrupted sleep period (FUSP) (minutes), measured over seven days, between baseline and EoS
42 days
Change in mean nocturia urinary frequency
Time Frame: 42 days

Change in proportion of patients achieving mean nocturnal urinary frequency <2, measured over seven days, between baseline and EoS
42 days
Change in patient self assessment of condition (PGI)
Time Frame: 42 days

Change in patient self assessment of condition measured by the patient global impression of Change questionnaire assessed at baseline and EoS. The Patient Global Impression (PGI) Scale is a patient-reported outcome instrument that captures a patient's overall self-assessment of their condition's severity or change following treatment. It is available in two versions, PGI-Severity (PGI-S) and PGI-Improvement (PGI-I), used to assess current disease severity and perceived treatment response, respectively.
42 days
Patient reported adverse events
Time Frame: 56 days

Number of treatment emergent adverse events, categorized according to MEdDRA terms, assessed at 3 weeks, 6 weeks and 2 weeks follow-up.
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LENS Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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