Purpose: This Phase 2 study evaluates the safety, tolerability, and efficacy of the medication TAK-360 in individuals with Narcolepsy Type 2 (NT2). TAK-360 is a novel, selective orexin-2 receptor (OX2R) agonist designed to enhance orexin system activity and improve wakefulness.

Inclusion:

Diagnosis of Narcolepsy Type 2 (without cataplexy)
18–70 years old

Study Requirements:

Narcolepsy medication washout
Overnight sleep studies
Daytime sleep testing
Daytime clinic visits
Daily electronic diaries
Routine safety monitoring

Interested in Participating?

If you are interested in learning more about the study, please contact the study coordinators below. A member of the research team will conduct a pre-screening to determine eligibility.

Study Contacts:

Reetu Joshi: rgjoshi@stanford.edu
Andrew Lee: andrewlee@stanford.edu

The KYRA Study – Takeda 2002 (TAK-360-2002)

Purpose: This Phase 2 study evaluates the safety, tolerability, and efficacy of the investigational medication TAK-360 in individuals with Idiopathic Hypersomnia (IH). TAK-360 is a novel, selective orexin-2 receptor (OX2R) agonist designed to improve wakefulness and sleep–wake stability.

Inclusion:

Diagnosis of Idiopathic Hypersomnia (IH)
18–70 years old

Study Requirements:

Idiopathic Hypersomnia medication washout (if applicable)
Overnight sleep studies
Daytime sleep testing
Daytime clinic visits
Daily electronic diaries
Routine safety monitoring

Interested in Participating?

If you are interested in learning more about the study, please contact the study coordinators below. A member of the research team will conduct a pre-screening to determine eligibility.

Study Contacts:

Reetu Joshi: rgjoshi@stanford.edu
Andy Lee: andrewlee@stanford.edu

For patients with Narcolepsy with Cataplexy (NT1) and Narcolepsy without Cataplexy (NT2)

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.

For patients with Idiopathic Hypersomnia

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.

Vibrance Study 3

Purpose: We are looking for participants with Idiopathic Hypersomnia (IH) to evaluate safety and efficacy of ALKS 2680 in individuals with IH. ALKS 2680 is a selective orexin-2 receptor agonist that aims to restore orexin signaling, thereby promoting wakefulness.

Inclusion:

IH, age 18-70, BMI≥18 and ≤40 kg/m²

Study Requirements:

Up to 2-week medication washout
2 overnight visits, 3 daytime sleep studies, up to 6 additional in-clinic visits, up to 6 virtual visits
Questionnaires, blood and urine samples, actigraphy monitoring, sleep diaries

Compensation:

Up to $2,800

Contact: cluu2@stanford.edu

ALKS-2680-301 Long Term Extension

Purpose: A long-term extension study to test the safety/efficacy of the compound ALKS-2680 in participants with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia

Inclusion:

Completed participation in previous Alkermes OX2R study (Vibrance 1, 2, or 3) with no persisting severe adverse events from the compound.

Study Requirements:

First year: in-clinic visits once every 3 months and monthly Zoom check-ins, one overnight sleep study and one daytime sleep study
Second year: in-clinic visits every 4 months and monthly Zoom check-ins until FDA approval of the compound

Contact: cluu2@stanford.edu

For patients with Delayed Sleep Phase Syndrome

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.

Tasimelteon in Delayed Sleep-Wake Phase Disorder

Purpose: This study evaluates the effects and safety of the investigational medication tasimelteon in individuals with Delayed Sleep-Wake Phase Disorder (DSWPD). Outcomes are assessed using sleep diaries, actigraphy, questionnaires, and at-home salivary collections.

Inclusion:

Meeting criteria for DSWPD
18–75 years old
BMI between 18 and 35 kg/m²

Study Requirements:

3-week screening phase
1-week placebo run-in
4-week treatment period (approximately 2 months total)
4 in-person study visits
Option to continue treatment for up to 11 months in an open-label extension
Questionnaires, blood and urine samples
Actigraphy monitoring and sleep diaries
At-home DLMO procedures with salivary collections

Contact: Mila Trabanino (milaludi@stanford.edu)

Other

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.

Genetic and Blood Markers in Kleine-Levin Syndrome

Purpose: This study aims to identify genetic, protein, or other biological markers associated with Kleine-Levin Syndrome (KLS), with the goal of developing minimally invasive tools to support diagnosis.

Inclusion:

Individuals diagnosed with Kleine-Levin Syndrome (KLS)
Healthy controls with no known sleep disorders who know a KLS participant

Study Requirements:

Completion of questionnaires
Saliva samples
Possible blood samples

Contact: Mila Trabanino (milaludi@stanford.edu)

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