Lemborexant for treating Delayed Sleep Phase Syndrome
Lemborexant in Delayed Sleep Phase Syndrome
PHASE4 · University of California, San Francisco · NCT06874855
This study tests if Lemborexant can help people with Delayed Sleep Phase Syndrome fall asleep faster and improve their daytime functioning.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06874855 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Lemborexant in reducing sleep onset latency in patients with Delayed Sleep Phase Syndrome (DSPS). Participants will receive either Lemborexant or a placebo nightly for two years, with their sleep patterns monitored through sleep logs and actigraphy. The study aims to determine if Lemborexant can help individuals with DSPS achieve better sleep timing and reduce daytime impairment caused by their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Delayed Sleep Phase Syndrome.
Not a fit: Patients with significant depression, anxiety disorders, or other sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and daytime functioning for patients with Delayed Sleep Phase Syndrome.
How similar studies have performed: Other studies have shown promise in using similar approaches for sleep disorders, but this specific application of Lemborexant is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Andrew D Krystal, MD, MS — University of California, San Francisco
- Study coordinator: Andrew D Krystal, MD, MS
- Email: andrew.krystal@ucsf.edu
- Phone: 415-476-7702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Delayed Sleep Phase Syndrome, Syndrome, Lemborexant