NocturiaPhase 4LENSNCT07840638
How Well and Safely Does Lemborexant Work for People Who Wake up at Night to Urinate (LENS)
A Phase 4 study testing Lemborexant tablets in people with Nocturia, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nocturia
- What is being tested?
- Lemborexant tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2026to 20 Jul 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp Edmonton
Edmonton, Alberta, T6G 2P4
About this study
Official title: 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.
Read the 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).
- Conditions
- Nocturia
- Being tested
- Lemborexant tablets, Placebo
- Keywords
- Nocturia, Lemborexant, Randomised Cross Over Trial
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant tabletsDrug
Also called Dayvigo
5mg (one tablet) orally at bedtime for weeks 1-3, with optional uptitration to 10mg (two tablets) for weeks 4-6.
PlaceboDrug
Matching placebo tablet, one at bedtime weeks 1-3, optionally two for weeks 4-6 to preserve masking
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Lemborexant then Placebo | Experimental | 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. Receives: Drug: Lemborexant tablets |
| Sequence B: Placebo then Lemborexant | Experimental | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean nocturia episodes per 24 hours
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.
Measured: 42 Days
Secondary outcomes (7)
Change in Epiworth Sleepiness Scale (ESS)
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
Measured: 42 days
Change in nocturia associated quality of life
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.
Measured: 42 days
Change in Insomnia Severity Index (ISI)
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.
Measured: 42 days
Change in mean reported first uninterrupted sleep period (FUSP)
Change in mean reported first uninterrupted sleep period (FUSP) (minutes), measured over seven days, between baseline and EoS
Measured: 42 days
Change in mean nocturia urinary frequency
Change in proportion of patients achieving mean nocturnal urinary frequency <2, measured over seven days, between baseline and EoS
Measured: 42 days
Change in patient self assessment of condition (PGI)
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.
Measured: 42 days
Patient reported adverse events
Number of treatment emergent adverse events, categorized according to MEdDRA terms, assessed at 3 weeks, 6 weeks and 2 weeks follow-up.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion20 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840638
- Sponsor's protocol ID
- LENS Study
- Acronym
- LENS
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lederer K, Benes H, Fine A, Shoffner S, Bacchelli S, Diaz DC, Batista JE, Rowles R, Marco TD, Meinel M. A randomised crossover trial of daridorexant for the treatment of chronic insomnia and nocturia. J Sleep Res. 2025 Dec;34(6):e70002. doi: 10.1111/jsr.70002. Epub 2025 Mar 13.
PubMed 40083090Dmochowski R, Brucker BM, Cole E, Kawahara S, Pulicharam R, Burk C, Tung A, Hale D. Economic Burden of Illness in Adult Patients with Nocturia. J Manag Care Spec Pharm. 2019 May;25(5):593-604. doi: 10.18553/jmcp.2019.18067. Epub 2019 Jan 24.
PubMed 30675816Rahman SN, Cao DJ, Monaghan TF, Flores VX, Vaysblat M, Moy MW, Agudelo CW, Lazar JM, Weiss JP. Phenotyping the Association between Nocturia and Hypertension: A Systematic Review and Meta-Analysis. J Urol. 2021 Jun;205(6):1577-1583. doi: 10.1097/JU.0000000000001433. Epub 2020 Oct 20.
PubMed 33081593Weiss JP, Wein AJ, van Kerrebroeck P, Dmochowski R, Fitzgerald M, Tikkinen KA, Abrams P. Nocturia: new directions. Neurourol Urodyn. 2011 Jun;30(5):700-3. doi: 10.1002/nau.21125.
PubMed 21661016Pesonen JS, Cartwright R, Vernooij RWM, Aoki Y, Agarwal A, Mangera A, Markland AD, Tsui JF, Santti H, Griebling TL, Pryalukhin AE, Riikonen J, Tahtinen RM, Vaughan CP, Johnson TM 2nd, Auvinen A, Heels-Ansdell D, Guyatt GH, Tikkinen KAO. The Impact of Nocturia on Mortality: A Systematic Review and Meta-Analysis. J Urol. 2020 Mar;203(3):486-495. doi: 10.1097/JU.0000000000000463. Epub 2019 Jul 31.
PubMed 31364920Hou XY, Zhang L, Zhang ZJ, Xu W, Ye LW, Zhao HY, Suo XH, Hong AJ. Nocturia: An overview of current evaluation and treatment strategies. World J Methodol. 2025 Dec 20;15(4):104696. doi: 10.5662/wjm.v15.i4.104696. eCollection 2025 Dec 20.
PubMed 40900851Everaert K, Herve F, Bosch R, Dmochowski R, Drake M, Hashim H, Chapple C, Van Kerrebroeck P, Mourad S, Abrams P, Wein A. International Continence Society consensus on the diagnosis and treatment of nocturia. Neurourol Urodyn. 2019 Feb;38(2):478-498. doi: 10.1002/nau.23939. Epub 2019 Feb 19.
PubMed 30779378Bliwise DL, Wagg A, Sand PK. Nocturia: A Highly Prevalent Disorder With Multifaceted Consequences. Urology. 2019 Nov;133S:3-13. doi: 10.1016/j.urology.2019.07.005. Epub 2019 Jul 13.
PubMed 31310770van Kerrebroeck P, Abrams P, Chaikin D, Donovan J, Fonda D, Jackson S, Jennum P, Johnson T, Lose G, Mattiasson A, Robertson G, Weiss J; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology in nocturia: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):179-83. doi: 10.1002/nau.10053. No abstract available.
PubMed 11857672Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.
PubMed 32585700Landry I, Hall N, Alur J, Filippov G, Reyderman L, Setnik B, Henningfield J, Moline M. Acute Cognitive Effects of the Dual Orexin Receptor Antagonist Lemborexant Compared With Suvorexant and Zolpidem in Recreational Sedative Users. J Clin Psychopharmacol. 2022 Jul-Aug 01;42(4):374-382. doi: 10.1097/JCP.0000000000001562. Epub 2022 Jun 24.
PubMed 35748777Togo Y, Kaizuka Y, Nagasawa S, Kajio K, Kondoh N, Taguchi K. Efficacy and Safety of Lemborexant for Insomnia Patients With Nocturia-A Prospective Study. Low Urin Tract Symptoms. 2024 Nov;16(6):e12534. doi: 10.1111/luts.12534.
PubMed 39389787