Clinical Research Studies and Trials

Clinical Trials

XYLO: A Blood Pressure Study for People with Narcolepsy

Purpose: We are seeking patients with Narcolepsy (Type 1 or Type 2) who are interested in switching from high-sodium oxybate (XYREM) to low-sodium oxybate (XYWAV). This study assesses the impact on blood pressure and cardiovascular health.

Inclusion:

  • Patients with Narcolepsy Type 1 (NT1) or Type 2 (NT2)
  • Currently taking high-sodium oxybate
  • Aged 18-70

Study Requirements:

  • Duration: 11 weeks
  • Visits: 6-8 visits at Redwood City Sleep Clinic
  • 24-hour blood pressure monitoring
  • Urine collection
  • Sleep and dosing diaries

Contact: Miran Cho (mirancho@stanford.edu)

If you're interested in the study and would like more information, please click here to complete the questionnaire. We’ll contact you if you qualify.

DUET: A Study of Xywav Over 9 Grams for Patients with Narcolepsy

Purpose: DUET is an open-label study to investigate the effects of XYWAV on sleepiness, polysomnography, and functional outcomes in participants with Idiopathic Hypersomnia (IH) or Narcolepsy (Type 1 or Type 2). This is measured through the completion of daily questionnaires, surveys, and change in polysomnogram measurements before and after treatment with XYWAV.

Inclusion:

  • NT1/NT2 already taking 9 grams of XYWAV, 18-75 years old

Exclusion:

  • Various medical/psychiatric conditions, pregnant, shift workers, planning to travel across more than 3 time zones during the study.

Study Requirements:

  • 10-21 weeks, clinic and virtual visits, overnight in-lab sleep studies, daily diaries.
  • participants will receive an active dose of XYWAV at no cost.

Contact: Reetu Joshi (rgjoshi@stanford.edu)

If you're interested in the study and would like more information, please click here to complete the questionnaire. We’ll contact you if you qualify.

The First Light Study- Takeda 3001

Purpose: This phase 3 study is testing the safety and efficacy of the compound TAK-861 in individuals with Narcolepsy Type 1. TAK-861 is a selective orexin-2 agonist and is designed to reduce daytime narcolepsy symptoms by restoring orexin signaling in the brain.

Inclusion:

  • Diagnosis of NT1, 16-70 years old, BMI 18-40 kg/m²

Study Requirements:

  • Narcolepsy medication washout
  • 3 overnight sleep studies
  • N3 daytime sleep studies
  • 5 daytime clinic visits
  • 2 days of 25-hr blood pressure monitoring
  • Daily e-diaries

Contact: Reetu Joshi (rgjoshi@stanford.edu)

If you're interested in the study and would like more information, please click here to complete the questionnaire. We’ll contact you if you qualify.

The Move Up Study - Takeda 2003

Purpose: A long-term extension study to test the safety/efficacy of the compound TAK-861 in participants with Narcolepsy Type 1

Inclusion:

  • Completed participation in previous Takeda OX2R study (TAK-861-2001, TAK-861-3001) with no persisting severe adverse events from the compound.

Study Requirements:

  • First 3 months: in-clinic morning appointments once every 2 weeks
  • 3-9 months: in-clinic morning appointments once every month
  • One overnight PSG/daytime MWT
  • After a year: in-clinic appointments once every 3 months until FDA approval of the compound

Dreem Headband Study

Purpose: We are looking for participants with Narcolepsy Type 1 to evaluate the usefulness of the Dreem 3 System headband to help diagnose and manage excessive sleepiness(hypersomnia) disorders. The Dreem 3S Headband is a new device intended to diagnose and monitor sleep disorders.

Inclusion:

  • NT1 who will washout narcolepsy medication, ≤18 years old.

Exclusion:

  • pregnant, shift workers, history of stoke/epilepsy, implanted hypoglossal nerve stimulator or AHI 3% >15 not adherent to positive airway pressure therapy, not willing to reduce/stop the medications taking for narcolepsy during the study

Study Requirements:

  • Total of 4-5 visits up to 2 weeks including
  • 6-day medication washout
  • 7 nights wearing Dreem at-home
  • Completing questionnaires and sleep diaries
  • 2 overnight in-lab sleep studies
  • 1 daytime in-lab sleep study

Compensation:

  • up to $2,000

Contact: Miran Cho (mirancho@stanford.edu)

If you're interested in the study and would like more information, please click here to complete the questionnaire. We’ll contact you if you qualify.

Vibrance study 1&2

Purpose: We are looking for participants with Narcolepsy (Type 1 or Type 2) to evaluate safety and efficacy of ALKS 2680 in NT1 and NT2. ALKS 2680 is a selective orexin-2 receptor agonist that aims to restore orexin signaling, and, thereby promote wakefulness and ameliorate cataplexy in patients with NT1/NT2.

Inclusion:

  • NT1 or NT2

Study Requirements:

  • F2-week medication washout
  • 2 overnight visits, up to 9 in-clinic visits, up to 12 virtual visits
  • Questionnaires, blood samples, actigraphy monitoring, sleep/cataplexy diaries

Compensation:

  • up to $2250 - $3350

Contact: Taylor Yoo (tjnyoo@stanford.edu)

If you're interested in the study and would like more information

We’ll contact you if you qualify.

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

Purpose: Stanford University and Mayo Clinic have partnered to evaluate the efficacy of low sodium oxybate (Xywav) on total sleep time in patients with idiopathic hypersomnia. The comprehensive assessments will yield detailed information about how low sodium oxybate affects sleep, breathing, and other physiological metrics, ultimately enhancing understanding of idiopathic hypersomnia.

Inclusion:

  • IH, recommended low sodium oxybate, 18-65 years old, BMI 18-35 kg/m², sleep duration ≥ 9 hours

Exclusion:

  • Various medical/psychiatric conditions, shift workers.

Study Requirements:

  • 3-5 months, 6-7 visits at Redwood City Sleep Clinic.
  • 2 24-hour in-lab sleep study, actigraphy monitoring, blood draw
  • participants will receive an active dose of XYWAV at no cost.

Contact: Miran Cho (mirancho@stanford.edu)

If you're interested in the study and would like more information, please click here to complete the questionnaire. We’ll contact you if you qualify.

FT218 in the Treatment of IH with an Open-Label Safety Extension

Purpose: We are looking for participants with Idiopathic Hypersomnia who would be interested in starting single dose sodium oxybate (Lumryz) to evaluate safety and efficacy of FT218 in IH

Inclusion:

  • IH, can be sodium oxybate Naïve or have taken Xywav or Xyrem in the past

Study Requirements:

  • 2-week randomized withdrawal period after the 10 week open-label period
  • participants can continue into the open label extension phase of the study and receive treatment for the next 20 weeks after the randomized withdrawal period
  • 17-22 visits (some virtual), blood draws, urine drug screen, questionnaires

Contact: Sara Lomba (slomba@stanford.edu)

Lemborexant in Delayed Sleep Phase Syndrome

Purpose: 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.

Inclusion:

  • Meeting criteria for DSPS, 18+ years old.

Exclusion:

  • Uncontrolled psychiatric/medical disorders, pregnant, impaired organ function, shift workers, known HIV positive, using medications affecting sleep.

Study Requirements:

  • 4 visits over 6 weeks
  • Questionnaires, blood samples, actigraphy monitoring, at-home DLMO procedure, sleep diaries

Contact: Sara Lomba (slomba@stanford.edu)

Validation of the Situational Sleepiness Scale

Purpose:In efforts to modernize clinical measurements of sleepiness, Stanford physicians partnered with X to develop the Situational Sleepiness Scale.

Inclusion:

  • All are eligible to participate.

Study Requirements:

  • This online survey takes about 5 minute to complete

Contact: Sara Lomba (slomba@stanford.edu)

If you are interested in participating in this study, please fill out the questionnaire at this link.

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

Purpose:To identify genes associated with sleep disorders such as obstructive sleep apnea, restless legs syndrome, insomnia, and other less common sleep disorders.

Inclusion:

  • Individuals with a scheduled appointment at Stanford Sleep Medicine Center or those who have undergone polysomnography at Stanford Sleep Clinic.

Study Requirements:

  • Complete the online Alliance sleep questionnaire (ASQ)
  • Provide a blood or saliva sample

Contact: Sara Lomba (slomba@stanford.edu)

Immunogenetics in Immune-mediated Encephalitis (IGNITE)

Purpose:The IGNITE project is examining immunogenetics in immune-mediated encephalitis. We are currently recruiting participants with autoimmune encephalitis and other related disorders to determine whether there is a genetic predisposition to autoimmune encephalitis, autoimmune cerebellar ataxias, and paraneoplastic neurological syndromes.

Inclusion:

  • Must be one month of age or older
  • Presence of well-characterized neuroglial antibodies in serum and/or cerebrospinal fluid, which moreover have to be detected with the appropriate methodology
  • Clinical presentation compatible with the detected neuroglial antibody based on previous knowledge reflected in the literature

Exclusion:

  • Absence of complete clinical and/or biological data
  • Alternative or doubtful diagnosis
  • Clinical presentation compatible with the detected neuroglial antibody based on previous knowledge reflected in the literature

Study Requirements:

  • Completing two surveys, and providing a saliva and/or a blood sample.

Contact: Sara Lomba (slomba@stanford.edu)

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.