Trial Outcomes & Findings for Lemborexant Shift Work Treatment Study (NCT NCT05344443)
NCT ID: NCT05344443
Last Updated: 2026-02-04
Results Overview
Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was recorded using the Consensus Sleep Diary, which participants completed daily.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Two weeks of Treatment
Results posted on
2026-02-04
Participant Flow
Recruitment of participants began in March 2022 and ended in December 2024. Participants were recruited primarily through flyers, with targeted recruitment at local hospitals.
Study participants completed baseline assessments, including sociodemographic questionnaires, clinical labs, and sleep measures (diaries, actigraphy) prior to randomization.
Participant milestones
| Measure |
Active Treatment
Participants randomized into this arm will receive Lemborexant (5-10mg).
|
Placebo Treatment
Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 participant in the active treatment group did not provide their age.
Baseline characteristics by cohort
| Measure |
Active Treatment
n=15 Participants
Participants randomized into this arm will receive Lemborexant (5-10mg).
|
Placebo Treatment
n=14 Participants
Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.8 Years
STANDARD_DEVIATION 9.3 • n=14 Participants • 1 participant in the active treatment group did not provide their age.
|
36.6 Years
STANDARD_DEVIATION 8.4 • n=14 Participants • 1 participant in the active treatment group did not provide their age.
|
37.2 Years
STANDARD_DEVIATION 8.7 • n=28 Participants • 1 participant in the active treatment group did not provide their age.
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
13 Participants
n=14 Participants
|
28 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
4 Participants
n=15 Participants
|
8 Participants
n=14 Participants
|
12 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
3 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=15 Participants
|
2 Participants
n=14 Participants
|
9 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=15 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
29 Participants
n=29 Participants
|
|
Diary-based daytime total sleep time
|
341.1 Minutes per day
STANDARD_DEVIATION 78.9 • n=13 Participants • Two participants in the active treatment and two participants in the placebo group were missing diary based total sleep time value at baseline.
|
332.9 Minutes per day
STANDARD_DEVIATION 66.2 • n=12 Participants • Two participants in the active treatment and two participants in the placebo group were missing diary based total sleep time value at baseline.
|
336.8 Minutes per day
STANDARD_DEVIATION 71.2 • n=25 Participants • Two participants in the active treatment and two participants in the placebo group were missing diary based total sleep time value at baseline.
|
|
Actigraphy-based daytime total sleep time
|
322.6 Minutes per day
STANDARD_DEVIATION 125.2 • n=9 Participants • Six participants in the active treatment and 5 participants in the placebo condition were missing usable actigraphy data at baseline.
|
286.4 Minutes per day
STANDARD_DEVIATION 59.8 • n=9 Participants • Six participants in the active treatment and 5 participants in the placebo condition were missing usable actigraphy data at baseline.
|
304.5 Minutes per day
STANDARD_DEVIATION 97.0 • n=18 Participants • Six participants in the active treatment and 5 participants in the placebo condition were missing usable actigraphy data at baseline.
|
PRIMARY outcome
Timeframe: Two weeks of TreatmentPopulation: Sleep diaries completed during daytime sleep attempts were the source of the treatment data. However, one participant (in the drug condition) failed to provide any useable diaries for daytime sleep attempts
Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was recorded using the Consensus Sleep Diary, which participants completed daily.
Outcome measures
| Measure |
Active Treatment
n=14 Participants
Participants randomized into this arm will receive Lemborexant (5-10mg).
|
Placebo Treatment
n=14 Participants
Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.
|
|---|---|---|
|
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary
|
362.7 Minutes per day
Standard Error 22.0
|
365.3 Minutes per day
Standard Error 22.4
|
SECONDARY outcome
Timeframe: Two weeks of treatmentPopulation: These analyses rely on wrist actigraphy data collected post-treatment. No actigraphy data were available in In 3 participants randomized to the placebo group and 1 participant in the drug condition.
Daytime total sleep time in minutes per day following a night shift averaged over the two-week treatment/placebo period. Daytime total sleep time in minutes per day was collected using daily actigraphy data from Actiwatches, which participants wore during the two week treatment period.
Outcome measures
| Measure |
Active Treatment
n=14 Participants
Participants randomized into this arm will receive Lemborexant (5-10mg).
|
Placebo Treatment
n=11 Participants
Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.
|
|---|---|---|
|
Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy
|
318.4 Minutes per day
Standard Error 21.1
|
324.0 Minutes per day
Standard Error 29.2
|
Adverse Events
Active Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Treatment
n=15 participants at risk
Participants randomized into this arm will receive Lemborexant (5-10mg).
|
Placebo Treatment
n=14 participants at risk
Participants randomized into this arm will receive a placebo medication which appears the same as the active treatment.
|
|---|---|---|
|
General disorders
Sleep paralysis
|
13.3%
2/15 • Number of events 2 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
0.00%
0/14 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
General disorders
Twisted ankle
|
6.7%
1/15 • Number of events 1 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
0.00%
0/14 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
6.7%
1/15 • Number of events 1 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
7.1%
1/14 • Number of events 1 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 1 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
0.00%
0/14 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/15 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
7.1%
1/14 • Number of events 1 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
General disorders
Grogginess
|
26.7%
4/15 • Number of events 5 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
0.00%
0/14 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
General disorders
Vivid dreaming/nightmare
|
20.0%
3/15 • Number of events 3 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
0.00%
0/14 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
General disorders
Fragmented sleep
|
20.0%
3/15 • Number of events 4 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
0.00%
0/14 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
|
General disorders
Irritability
|
0.00%
0/15 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
7.1%
1/14 • Number of events 1 • Events were collected beginning at randomization until the end of follow-up, up to 5 weeks.
Adverse events were assessed by an open-ended question by the PI. Details on the event, the duration, and the likelihood of whether the event was related to study medication was obtained.
|
Additional Information
Aric A. Prather, PhD
University of California, San Francisco
Phone: 4154767758
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place