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Can a Low-Sodium sleep drug ease daytime sleepiness in two sleep disorders?

NCT ID NCT05875974

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether a low-sodium form of oxybate, called XYWAV, can reduce daytime sleepiness and improve daily function in adults aged 18 to 75 with idiopathic hypersomnia or narcolepsy. Participants take the oral solution at night, with doses adjusted to their needs, and researchers measure changes in sleepiness scores and sleep quality. The study aims to see if this medication helps people stay awake and function better during the day.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-sodium oxybate oral solution (XYWAV)
What this could lead to
If it works, this could offer a treatment option that reduces daytime sleepiness and improves daily functioning for people with idiopathic hypersomnia or narcolepsy.
What could go wrong
This is a phase 4 study, so the drug is already approved, but it may not work for everyone and can cause side effects like dizziness, nausea, or sleep-related breathing problems.

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

199 people

The number who actually took part.

Started

Jul 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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.

Key Inclusion Criteria: * Is 18 to 75 years of age (inclusive) at the time of signing the informed consent form (ICF) * Has a primary diagnosis of IH meeting International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria or narcolepsy (Type 1 or Type 2) meeting ICSD-3 or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria. * If not currently taking oxybate medication, has clinically significant symptoms of Excessive daytime sleepiness (EDS) with an ESS score \> 10 at Screening Visit 1. If currently taking oxybate medication, has an ESS score \> 10 at the Baseline Visit 2 polysomnography (after washout period). Note: Not applicable for participants entering the Narcolepsy \>9-gram cohort (see additional criteria below for the Narcolepsy \>9-gram cohort). * If currently treated with anticataplectics and/or alerting agents, has been taking the same dosage for at least 1 month prior to Screening Visit 1 and has no current plans to adjust the dosage during the study period. Note: Alerting agents refer to either traditional stimulants (eg, amphetamines, methylphenidates) or wake-promoting agents (eg, modafinil, pitolisant, solriamfetol). Additional Inclusion Criteria for Participants in the Exploratory Narcolepsy \>9-Gram Cohort * Is on a current treatment regimen including XYWAV at a dosage of 9 grams Key Exclusion Criteria: * Shows evidence of a previous untreated or inadequately treated sleep disorder considered by the investigator to negatively impact the conduct of the study, including sleep-disordered breathing, parasomnias, circadian rhythm sleep disorders, or restless legs syndrome determined by a previous sleep-laboratory diagnosis or interview utilizing modules of the Diagnostic Interview for Sleep Patterns and Disorders. * Shows evidence of untreated or inadequately treated sleep-disordered breathing during Baseline Visit 2 polysomnography defined as an Apnea/Hypopnea Index (AHI) \> 10, using the US Centers for Medicare and Medicaid Services rules (CMS.gov). * Has a history or presence of any unstable or clinically significant medical condition (chronic pain condition that may impact sleep), behavioral or psychiatric disorder (including active suicidal ideation or current or past \[within 1 year\] major depressive episode), or history or presence of another neurologic disorder or surgical history that might affect the participant's safety and/or interfere with the conduct of the study, in the opinion of the investigator. * Has recently taken (ie, within 1 month prior to screening), is taking, or plans to take any of the following: * A substance or medication contraindicated with XYWAV use, ie. specifically alcohol and sedative hypnotics * A medication with a known drug-drug interaction with XYWAV * A medication that may have similar EEG effects to XYWAV * Medications known to have clinically significant CNS sedative effects * Other medications, natural health products, or substances from which the participant experiences clinically significant sedation Additional Exclusion Criterion for Participants in the Exploratory Narcolepsy \>9-Gram Cohort • Any past or current medical conditions or experience that, in the investigator's clinical judgment, would preclude further increases in the current oxybate medication dosage beyond 9 grams

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence idiopathic hypersomnia narcolepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic hypersomnia Narcolepsy

Contacts and locations

Locations

  • AMNDX Inc

    Markham, Ontario, L3R 1A3, Canada

  • Abington Neurological Associates, LTD

    Abington, Pennsylvania, 19001, United States

  • Amnova Clinical Research

    Irvine, California, 92604, United States

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Centricity Research Rincon - DBA IACT Health Southeast Lung Associates Research

    Rincon, Georgia, 31326, United States

  • Cleveland Clinic Main Campus - Clinical Research Unit

    Cleveland, Ohio, 44195, United States

  • Clinical Neurophysiology Services, P.C.

    Sterling Heights, Michigan, 48314, United States

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054, United States

  • Comprehensive Sleep Medicine Associates

    Houston, Texas, 77030, United States

  • Florida Hospital for Children

    Winter Park, Florida, 32789, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Geisinger Clinic

    Scranton, Pennsylvania, 18510, United States

  • Heritage Medical Research Clinic, University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • Intrepid Research

    Cincinnati, Ohio, 45245, United States

  • Johda Tishon Inc

    Toronto, Ontario, M5S 3A3, Canada

  • Long Beach Research Institute

    Lakewood, California, 90805, United States

  • Meris Clinical Research, LLC

    Brandon, Florida, 33511, United States

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30328, United States

  • Neurocare, Inc., dba Neurocare Center for Research

    Newtown, Massachusetts, 02459, United States

  • Ohio Sleep Medicine and Neuroscience Institute

    Dublin, Ohio, 43017, United States

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85253, United States

  • PharmaDev Clinical Research Institute, LLC

    Miami, Florida, 33176, United States

  • SDS Clinical Trials, Inc.

    Santa Ana, California, 92705, United States

  • Santa Monica Clinical Trials

    Los Angeles, California, 90025, United States

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama, 35213, United States

  • Sleep Therapy & Research Center

    San Antonio, Texas, 78229, United States

  • St. Lukes Hospital Medical Center

    Chesterfield, Missouri, 63017, United States

  • Stanford School of Medicine

    Redwood City, California, 94063, United States

  • Stern Research Partners, LLC

    Huntersville, North Carolina, 28078, United States

  • TriValley Sleep Center

    San Ramon, California, 94583, United States

  • Tricoastal Narcolepsy and Sleep Disorders Center

    Sugar Land, Texas, 77479, United States

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