Trial · NCT05344443

Lemborexant Shift Work Treatment Study

NCT05344443, Phase 4, Completed, University of California, San Francisco; results first posted 2026-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lemborexant Shift Work Treatment Study. Trials, record NCT05344443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05344443

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lemborexant Shift Work Treatment Study
NCT number: NCT05344443
Status: Completed
Phases: Phase 4
Enrollment: 29 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Shift-Work Related Sleep Disturbance
Interventions: Lemborexant, Placebo
First posted: 2022-04-25
Last updated: 2026-02-04
Results first posted: 2026-02-04
Limitations and caveats: Due to challenges in recruitment and difficulties obtaining daytime sleep diaries and wrist actigraphy data, this study is likely underpowered, and the findings should be interpreted with caution.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary	Two weeks of Treatment	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.
Secondary	Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy	Two weeks of treatment	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary	Two weeks of Treatment	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	Minutes per day	MEAN
SECONDARY	Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy	Two weeks of treatment	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.	Minutes per day	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary	Active Treatment	362.7	Standard Error 22.0	Minutes per day
Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary	Placebo Treatment	365.3	Standard Error 22.4	Minutes per day
Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy	Active Treatment	318.4	Standard Error 21.1	Minutes per day
Daytime Total Sleep Time in Minutes Per Day Measured by Actigraphy	Placebo Treatment	324.0	Standard Error 29.2	Minutes per day

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Treatment	15
Overall Study	STARTED	Placebo Treatment	14
Overall Study	COMPLETED	Active Treatment	15
Overall Study	COMPLETED	Placebo Treatment	13
Overall Study	NOT COMPLETED	Active Treatment	0
Overall Study	NOT COMPLETED	Placebo Treatment	1

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Grogginess	General disorders	Active Treatment	4	15	5
other	Grogginess	General disorders	Placebo Treatment	0	14	0
other	Vivid dreaming/nightmare	General disorders	Active Treatment	3	15	3
other	Vivid dreaming/nightmare	General disorders	Placebo Treatment	0	14
other	Fragmented sleep	General disorders	Active Treatment	3	15	4
other	Fragmented sleep	General disorders	Placebo Treatment	0	14	0
other	Irritability	General disorders	Active Treatment	0	15	0
other	Irritability	General disorders	Placebo Treatment	1	14	1
other	Sleep paralysis	General disorders	Active Treatment	2	15	2
other	Sleep paralysis	General disorders	Placebo Treatment	0	14

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active Treatment	0	15
Total, all-cause mortality	Placebo Treatment	0	14
Total, other adverse events	Active Treatment	5	15
Total, other adverse events	Placebo Treatment	1	14
Total, serious adverse events	Active Treatment	0	15
Total, serious adverse events	Placebo Treatment	0	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42844407	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active Treatment vs Placebo Treatment: deaths from any cause	Trial comparisons
Active Treatment vs Placebo Treatment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05344443

GET https://conductscience.org/api/trials/v1/NCT05344443/registered

API reference For AI assistants