Shift-Work Sleep Disorder
Conditions
Keywords
Daytime sleep episodes, Polysomnographic recordings, Subjective sleep evaluations, Total sleep time (TST), Wake after sleep onset (WASO)
Brief 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.
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).
Interventions
DRUGLemborexant 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.
OTHERMatching Placebo
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.
Sponsors
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomised, double-blind, placebo-controlled crossover mono-centric feasibility study
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must fulfill all of the following inclusion criteria to be eligible for inclusion in this study: 1. Men or women aged between 20 and 65 years, inclusive 2. Be willing and able to give informed consent for study participation 3. Participants must not have done shiftwork in the past year 4. 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. 5. 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). 6. 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. 7. Self-reported bedtime was between 9 pm and midnight on 4-7 nights per week.
Exclusion criteria
Participants must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total sleep duration (objective measure) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total sleep duration (subjective measure) | during the intervention | 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 |
| Wake after sleep onset (subjective measure) | during the intervention | 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. |
Countries
Canada
Outcome results
None listed