Shift-Work Sleep DisorderPhase 2NCT06231641
The Effects of Lemborexant on the Ability to Sleep During Daytime
A Phase 2 study testing Lemborexant 5 MG [Dayvigo] in people with Shift-Work Sleep Disorder, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
This study aim to evaluate whether a dose of 5 mg of lemborexant, as compared to a placebo, may improve daytime recovery sleep, without producing lingering sleepiness during wakefulness, using a 3-day simulated night shift protocol in the lab under constant monitoring. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- Lemborexant 5 MG [Dayvigo]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jan 2024to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must fulfill all of the following inclusion criteria to be eligible for inclusion in this study:
- Men or women aged between 20 and 65 years, inclusive
- Be willing and able to give informed consent for study participation
- Participants must not have done shiftwork in the past year
- Normal vital signs values are: oral body temperature between 36.1 and 37.5 ºC (95 and 99.5 °F), supine SBP between 90 and 140 mmHg inclusive; supine DBP between 55 and 90 mmHg inclusive; heart rate between 50 and 100 bpm inclusive.
- Be willing to comply with all study requirements and procedures for the duration of the study, including refraining from consuming alcohol 48 hours prior to each experimental visit and grapefruit products (juice or fruit itself), Seville orange, lime, pomelo, carambola and pomegranate during all the duration of the study (from Visit 1 to Visit 4).
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- Women who:
- Are postmenopausal, with amenorrhea for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If of childbearing potential agree to practice effective double barrier methods of contraception, from the time of the signing of informed consent through the last dose of study drug and for 30 days after dosing stops (1 ovulatory cycle), or agree to completely abstain from intercourse.
- Men with women partners of childbearing potential are also expected to practice effective barrier methods of contraception from the time of signing informed consent through the last dose of study drug and for 30 days after dosing stops.
- Self-reported bedtime was between 9 pm and midnight on 4-7 nights per week.
Who cannot join
- Participants must not meet any of the following exclusion criteria:
- Body mass index > 32 as calculated from the participant's height (m) and weight (kg); weight (kg)/square height (m²)
- Presence of a sleep disorder, such as a diagnosis of insomnia, narcolepsy, sleep paralysis, active somnambulism (history of childhood somnambulism is accepted), hypnagogic/ hypnopompic hallucinations, and REM behavior disorder, will be excluded based on the clinical interview. For sleep apnea syndrome, an apnea-hypopnea index > 15 per hour of sleep on the first screening night will be used as an exclusion criterion. For periodic limb movement disorder, an index of periodic limb movements during sleep associated with an arousal > 15 per hour of sleep on the first screening night will be used as an exclusion criterion.
- History of epilepsy
- Any previous serious head injury or stroke
- Any evidence of psychiatric disorder (including Beck Depression Inventory [BDI] ≥ 20 at screening, or a score of 3 on item related to suicidal ideas)
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- Evidence of any clinically significant, or unstable, acute or chronically progressive medical or surgical disorder (including planned medical procedures that may impact sleep), or any condition that may interfere with the absorption, metabolism, distribution, or excretion of the study drug, or may affect the participant's safety
- Clinically significant and abnormal electrocardiogram (ECG; including QTc ≥ 450 ms for males, 460 ms for females) or a history of cardiovascular disease including poorly controlled hypertension, ischemic heart disease, arrhythmia, or severe heart failure
- Severe hepatic impairment
- Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene) and alcohol test (breathalyzer), at screening and before each experimental visit
- Current use of medications that are moderate or strong CYP3A4 inhibitors or inducers or CYP2B6 substrates (Appendix 1)
- Use of any substance with psychotropic effects or properties known to affect sleep/wake, including hypnotics, neuroleptics, opioid derivatives, antihistamines, stimulants, antidepressants, within one week or five half-lives (whichever is longer) prior to PSG screening
- Use of any over-the-counter sleep medications including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St John's Wort (Hypericum perforatum), Alluna (herbal sleep supplement with valerian root), and hemp within one week or five half-lives (whichever is longer) prior to screening
- Consumption of xanthine-containing beverages (i.e., tea, coffee, or cola) of more than 5 cups or glasses per day
- Participation in any other trial within 30 days before the screening visit
- Any travel across more than one time zone in the month prior to screening at any time during the study
- Other exclusion criteria based on adverse events (AE) or serious adverse events (SAE) reported in the Investigator Brochure
- Women who are pregnant, during the study or within one month after the study, or are breastfeeding
- Individuals may be excluded from participating in the study based on the clinician's judgement.
- Participants with lactose or galactose intolerance (galactosemia or glucose-galactose malabsorption)
Trial locations and contacts
1 site in 1 country.
Canada1 site
CIUSSS du Nord de l'ile de Montreal (CIUSSS-NIM) - Hôpital du Sacré-Cœur de Montréal (HSCM)
Montreal, Quebec, H4J 1C5
About this study
Official title: The Effects of Lemborexant on the Ability to Sleep During Daytime: A Feasibility Study to Evaluate the Potential of Lemborexant to Treat Shift Work Disorder
This study aim to evaluate whether a dose of 5 mg of lemborexant, as compared to a placebo, may improve daytime recovery sleep, without producing lingering sleepiness during wakefulness, using a 3-day simulated night shift protocol in the lab under constant monitoring.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed conset will undergo 2 screening visits to determine eligibility for study entry. Selected participants will then stay twice in the lab (active treatment condition and placebo condition), each visit lasting approximately 4 days. Participants will stay awake across the night and sleep during the day. Only the experimental condition will be different between the two visits (lemborexant or placebo). These experimental visits will be double-blind, in counterbalanced order and separated by an interval of at least 2 weeks (washout period).
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- Lemborexant 5 MG [Dayvigo], Matching Placebo
- Keywords
- Daytime sleep episodes, Polysomnographic recordings, Subjective sleep evaluations, Total sleep time (TST), Wake after sleep onset (WASO)
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 5 MG [Dayvigo]Drug
Lemborexant 5 mg will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.
Matching PlaceboOther
Matching placebo will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment condition | Active comparator | Lemborexant at a 5mg dose is delivered in a film-coated tablet Receives: Drug: Lemborexant 5 MG [Dayvigo] |
| Placebo condition | Placebo comparator | Placebo is delivered in a film-coated tablet Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep duration (objective measure)
Assess the efficacy of lemborexant compared to placebo on PSG measured total sleep time (TST) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition.
Measured: during the intervention
Wake after sleep onset (objective measure)
Assess the efficacy of lemborexant compared to placebo on polysomnographically (PSG) measured wake after sleep onset (WASO) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition
Measured: during the intervention
Secondary outcomes (2)
Total sleep duration (subjective measure)
Evaluate the participant-reported daytime recovery sleep quality, measured as subjective TST (sTST), under lemborexant in comparison to placebo using the mean data of the second and third daytime sleep episodes in each condition
Measured: during the intervention
Wake after sleep onset (subjective measure)
Evaluate the participant-reported daytime recovery sleep quality, measured as subjective WASO (sWASO), under lemborexant in comparison to placebo using the mean data of the second and third daytime sleep episodes in each condition.
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start11 Jan 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Why it stopped: In agreement with all parties, the project was closed on March 31 due to recruitment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Sleep DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, double-blind, placebo-controlled crossover mono-centric feasibility study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Desautels, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231641
- Sponsor's protocol ID
- DVG-IIS-M001-1008
- Status last verified
- May 2026
- First submitted
- 17 Jan 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lemborexant on the Ability to Sleep During Daytime: A Feasibility Study to Evaluate the Potential of Lemborexant to Treat Shift Work Disorder
- ClinicalTrials.gov ID
- NCT06231641
- Acronym / sponsor ID
- DVG-IIS-M001-1008
- Conditions
- Shift-Work Sleep Disorder
- Keywords
- Daytime sleep episodes, Polysomnographic recordings, Subjective sleep evaluations, Total sleep time (TST), Wake after sleep onset (WASO)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In agreement with all parties, the project was closed on March 31 due to recruitment challenges.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aim to evaluate whether a dose of 5 mg of lemborexant, as compared to a placebo, may improve daytime recovery sleep, without producing lingering sleepiness during wakefulness, using a 3-day simulated night shift protocol in the lab under constant monitoring.
Detailed description
After being informed about the study and potential risks, all patients giving written informed conset will undergo 2 screening visits to determine eligibility for study entry. Selected participants will then stay twice in the lab (active treatment condition and placebo condition), each visit lasting approximately 4 days. Participants will stay awake across the night and sleep during the day. Only the experimental condition will be different between the two visits (lemborexant or placebo). These experimental visits will be double-blind, in counterbalanced order and separated by an interval of at least 2 weeks (washout period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, double-blind, placebo-controlled crossover mono-centric feasibility study
| Arm | Type | Receives |
|---|---|---|
| Active treatment condition | Active comparator | Drug: Lemborexant 5 MG [Dayvigo]Lemborexant at a 5mg dose is delivered in a film-coated tablet |
| Placebo condition | Placebo comparator | Other: Matching PlaceboPlacebo is delivered in a film-coated tablet |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must fulfill all of the following inclusion criteria to be eligible for inclusion in this study:
- Men or women aged between 20 and 65 years, inclusive
- Be willing and able to give informed consent for study participation
- Participants must not have done shiftwork in the past year
- Normal vital signs values are: oral body temperature between 36.1 and 37.5 ºC (95 and 99.5 °F), supine SBP between 90 and 140 mmHg inclusive; supine DBP between 55 and 90 mmHg inclusive; heart rate between 50 and 100 bpm inclusive.
Key exclusion criteria (20 listed)
- Body mass index > 32 as calculated from the participant's height (m) and weight (kg); weight (kg)/square height (m²)
- Presence of a sleep disorder, such as a diagnosis of insomnia, narcolepsy, sleep paralysis, active somnambulism (history of childhood somnambulism is accepted), hypnagogic/ hypnopompic hallucinations, and REM behavior disorder, will be excluded based on the clinical interview. For sleep apnea syndrome, an apnea-hypopnea index > 15 per hour of sleep on the first screening night will be used as an exclusion criterion. For periodic limb movement disorder, an index of periodic limb movements during sleep associated with an arousal > 15 per hour of sleep on the first screening night will be used as an exclusion criterion.
- History of epilepsy
- Any previous serious head injury or stroke
- Any evidence of psychiatric disorder (including Beck Depression Inventory [BDI] ≥ 20 at screening, or a score of 3 on item related to suicidal ideas)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant 5 MG [Dayvigo]Lemborexant 5 mg will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening. | Drug | Active treatment condition |
| Matching PlaceboMatching placebo will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening. | Other | Placebo condition |
Primary outcome
Total sleep duration (objective measure)
Time frame: during the intervention
Assess the efficacy of lemborexant compared to placebo on PSG measured total sleep time (TST) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition.
Wake after sleep onset (objective measure)
Time frame: during the intervention
Assess the efficacy of lemborexant compared to placebo on polysomnographically (PSG) measured wake after sleep onset (WASO) during daytime recovery sleep using the mean data of the second and third daytime sleep episodes in each condition
2 secondary outcomes
Total sleep duration (subjective measure)
Time frame: during the intervention
Wake after sleep onset (subjective measure)
Time frame: during the intervention
Results and safety
The study was stopped early (reason given: In agreement with all parties, the project was closed on March 31 due to recruitment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lemborexant 5 MG [Dayvigo] in people with Shift-Work Sleep Disorder, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: In agreement with all parties, the project was closed on March 31 due to recruitment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep duration (objective measure) (time frame: during the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.