New study tests sleep drug for night owls stuck on a late clock
NCT ID NCT06874855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug Lemborexant helps people with delayed sleep phase syndrome fall asleep faster at their desired bedtime. Fifteen adults will take either the drug or a placebo nightly for up to 2 years, tracking sleep with logs and a wrist monitor. The goal is to see if the drug can shift sleep timing and reduce daytime sleepiness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- Participants will be required to be 18 years of age or older and have delayed sleep phase syndrome (DSPS). Questionnaires will be used to identify potential confounders and to confirm a potential diagnosis of DSPS based on ICSD3 criteria: a) Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime). b) Subjects not able to fall asleep if trying to sleep before the later bedtime; c) This is interfering with their wishes/having a social impact. Concomitant medications will be allowed, though dosages will be required to remain fixed throughout participation in the study. The participant also needs to be willing and able to comply with all aspects of the protocol. Exclusion Criteria: * Clinically significant depression (PHQ-9 score of 10 or more), anxiety disorder (GAD- 7 score of 10 or more), substance use disorder, any other sleep disorder, or any medical disorder/therapy that could interfere with the trial * Use of medications with significant effects on sleep-wake function (insomnia therapies, stimulants)- unless they are discontinued at least 5 half-lives prior to study participation. Non-sedative antidepressants or SSRI will be allowed if at a stable dose in the absence of concomitant severe depression or severe anxiety. * Use of CYP3A inhibitors and CYP3A inducers, at least 1 week (or five half-lives, whichever is longer) prior to the first day of the baseline phase. * Pregnancy (verified by urine pregnancy test on visits 1, 2, and 3) or plan to become pregnant in the next 3 months or currently breastfeeding. * Shift workers or subjects working unusual hours. * Transmeridian travel across more than 3 time zones 4 weeks prior to the screening phase. * Transmeridian travel across more than 2 time zones during this trial (including the screening phase). * Having a positive drug test or being unwilling to refrain from using illegal drugs or marijuana during this trial. * Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, or laboratory test results that require medical treatment. * Impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) \> 1.5 times the Upper Limit of Normal). * Known to be human immunodeficiency virus positive.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Delayed sleep phase syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of California San Francisco
RECRUITINGSan Francisco, California, 94107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.