Clinical Research Studies and Trials

Alliance Sleep Questionnaire Data Repository and Study of Genetic & Blood Markers in Sleep Disorders

Stanford Sleep Medicine is conducting a study to identify gene(s) associated with or responsible for the development of sleep disorders in humans. To be eligible to participate, you must have an appointment scheduled at the Stanford Sleep Medicine Center for a diagnosis or follow-up care related to disorders, such as obstructive sleep apnea, restless legs syndrome, insomnia, or other less common sleep disorders. If you have undergone a polysomnography at Stanford Sleep Clinic, you may be eligible to participate. As a participant, you will need to complete the Alliance sleep questionnaire (ASQ), an IRB-approved research protocol, and a method of data collection. You will also need to provide either a blood or saliva sample, which will be stored in Stanford's ASQ Data Repository.

Please email Mira Cho if you have any questions.

Avadel

Stanford has partnered with Avadel Ireland to conduct an open label study for those diagnosed with Narcolepsy with or without Cataplexy. This study is a long-term extension study, investigating the safety and efficacy of Avadel Ireland's newest once-nightly sodium oxybate medication. Dr. Emmanuel Mignot at Stanford has 8 patients from across the country actively enrolled, with enrollment for new patients closed. All patients visit the Stanford Redwood City Sleep Clinic monthly, to have their sleepiness levels, adverse events, and overall well-being assessed while on the new medication.

If you would like to learn more about the opportunity to participate in studies similar to this, please email Saloni Dangoria with any inquiries.

Axesome

Stanford has partnered with Axsome Therapeutics to conduct a double-blind, placebo-controlled clinical trial for Narcolepsy Type 1 patients. This trial tests the efficacy, safety, and tolerability of reboxetine in patients who experience episodes of cataplexy and excessive daytime sleepiness. The study will include a screening period up to 4 weeks, followed by a 4-week treatment period, and a 1-week follow-up. During the treatment period, participants will be randomized into a placebo or treatment group. Participants who successfully complete the treatment period are eligible to enroll in a long-term extension period, which lasts up to 28 weeks.

If you have been diagnosed with Narcolepsy with cataplexy and are interested in participating, please email Saloni Dangoria.

Ignite

The IGNITE project is examining immunogenetics in immune-mediated encephalitis. We are currently recruiting potential participants with autoimmune encephalitis and other related disorders to complete a questionnaire, provide a saliva sample, and an optional blood sample. The goal of this project is to determine whether there is a genetic predisposition to autoimmune encephalitis, autoimmune cerebellar ataxias, and paraneoplastic neurological syndromes.

Please email Sara Lomba with any questions. If you feel that you may be a good fit for this study and are interested, please fill out the prescreening questionnaire at this link: https://redcap.link/8ogrg26f

Impact of Low Sodium Oxybate on Total Sleep Time in Patients with Idiopathic Hypersomnia

Stanford University and Mayo Clinic have partnered to evaluate the efficacy of low sodium oxybate on total sleep time in patients with idiopathic hypersomnia. To achieve this, Stanford is conducting a 3-5-month trial for individuals with idiopathic hypersomnia and is currently seeking participants. If you meet the eligibility criteria, you will need to visit the Redwood City Sleep Clinic a total of 6 to 7 times. These visits will involve two 24-hour sleep studies, actigraphy monitoring, two blood draws, and various other activities that will be conducted during your appointments. This comprehensive assessment will yield detailed information about how low sodium oxybate affects sleep, breathing, and other physiological metrics, ultimately enhancing understanding of idiopathic hypersomnia. Participants will be compensated for their time and effort.

Please email Mira Cho if you have any questions.

Lemborexant

Stanford has partnered with Eisai and UCSF to explore the potential benefits of Lemborexant, a melatonin agonist used to treat insomnia, in Delayed Sleep Phase Syndrome. Stanford will recruit 30 participants to participate in a 6-week trial to evaluate the safety and efficacy of Lemborexant. The trial period includes 4 study visits at Stanford Redwood City Sleep Clinic and a 2-week treatment phase where participants will have equal chances of receiving treatment or placebo. Participants will be compensated up to $1,280 for their time and effort.

Please email Sara Lomba with any questions. If you feel that you may be a good fit for this study and are interested, please fill out the prescreening questionnaire at this link: https://redcap.link/qm6wcnd3

PN-PROS

Stanford University is collaborating with Boston Children's Hospital on The Narcolepsy Patient Reported Outcomes Scale (PN-PROS) to identify important symptoms of pediatric narcolepsy from the patient's perspective. The study aims to improve the management and care of pediatric Narcolepsy. Eligible participants for this study are between the ages of 9-17 who are diagnosed with either narcolepsy or obstructive sleep apnea. The online survey via REDCap will take approximately 30 minutes to complete. One week after completing the initial questionnaire, participants will follow-up with the completion of an additional questionnaire. Participants will be compensated for their time and effort after completing the questionnaires in their entirety.

If you feel that you are a good fit, please fill out the prescreening questionnaire at this link: https://redcap.link/stanford.pnpros. Please email Mira Cho if you have any questions.

Situational Sleepiness Scale Validation

In efforts to modernize clinical measurements of sleepiness, Stanford physicians partnered with X to develop the Situational Sleepiness Scale. All are eligible to participate in this quick 5-minute survey.

If you are interested in participating in this study, please fill out the questionnaire at this link: https://is.gd/stanfordsleepSSS. Please email Sara Lomba with any questions.

Takeda

Stanford is partnering with Takeda Pharmaceuticals for an exciting new clinical trial for Narcolepsy patients. If you have been diagnosed with narcolepsy with or without cataplexy, you may be eligible in participating! The study drug, TAK-861, is one of the first pharmaceutical drugs to directly target the orexin peptide in the brain, to reduce daytime sleepiness, reduce cataplectic events, and increase wakefulness. You will have 4 out of 5 chances to be on active treatment versus placebo (inactive control) for 8 weeks. The study trial will include a screening period of up to 2 months, an 8-week treatment period, and the option to enroll in a long-term study extension where all participants will be guaranteed active treatment. Involvement in the trial requires 5 daytime visits and 3 overnight visits at the Stanford Sleep Clinic in Redwood City, and study travel will be fully accommodated and arranged for you. Patients will be compensated for their time and effort in the study.

If you would like to read more about the study, please visit https://www.clinicaltrials.gov/ct2/show/NCT05687903?term=TAK-861&draw=2&rank=3x. If you are interested in participating or have any further questions, please email Saloni Dangoria.

Validation of Circadian Biomarker

The Validation of Circadian Biomarkers Study is recruiting adult participants with either advanced or delayed sleep phase disorder. Involvement in this study will last for one week, to better understand the biomarkers associated with circadian timing. Participants in this study will undergo one week of actigraphy monitoring, a blood draw at the Stanford Clinic in Redwood City, and an at-home dim light melatonin onset (DLMO) task. Participants will be compensated $75 for their time and effort upon completion of their involvement. All participants who complete their DLMO will be provided with their results.

Please email Sara Lomba with any questions. If you feel that you may be a good fit for this study and are interested, please fill out the prescreening questionnaire at this link: https://redcap.link/qm6wcnd3

Vanda

Stanford has partnered with Vanda Pharmaceuticals to evaluate the safety and efficacy of Tasimelteon in Delayed Sleep-Wake Phase Disorder (DSWPD). Tasimelteon is currently used as a treatment for non-24-hour-Sleep-Wake-Disorder, by activating melatonin receptors in the brain. This study is recruiting participants with DSWPD for a 2-month long trial, which includes 4 on-site visits to the Stanford Redwood City Sleep Clinic and a 4-week long randomized treatment phase, with equal chances to be on treatment or placebo. This project compensates up to $600 for time and effort for participants.

Please email Sara Lomba with any questions. If you feel that you may be a good fit for this study and are interested, please fill out the prescreening questionnaire at this link: https://redcap.link/8adf73ja