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Idiopathic HypersomniaPhase 4NCT05837091

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

A Phase 4 study testing Low Sodium Oxybate, 24-hour polysomnography and Nextsense EEG earbuds in people with Idiopathic Hypersomnia, run by Mayo Clinic at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Idiopathic Hypersomnia
What is being tested?
Low Sodium Oxybate, 24-hour polysomnography and Nextsense EEG earbuds
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
4 sitesUnited States
Study dates
14 Feb 2024to Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)
  • Subjects aged 18 - 65 years
  • BMI between 18 and 35 kg/m2
  • Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries
  • Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)
  • Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care.
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  • Subject must be willing to postpone LSO therapy until all baseline assessments completed
  • If treated with wake promoting agents, traditional stimulants and/or antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study
  • Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 30 days after the last dose of study drug.

Who cannot join

  • Succinic semialdehyde dehydrogenase deficiency, porphyria
  • Other central nervous system diseases: neurodegenerative diseases, , seizure disorders or history of head trauma associated with loss of consciousness
  • Lifetime history of suicide attempt or suicidal ideation in the past six months, including answer to question #9 on PHQ-9 ≥1; PHQ-9 total score > 10; prior history of psychotic episodes; active major depressive disorder
  • Change to psychiatric medication(s)/stimulant(s) within last 3 months
  • History of chronic alcohol or drug abuse within the prior 12 months
  • Malignant neoplastic disease requiring therapy within the prior 12 months
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  • Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study
  • Renal or hepatic impairment
  • Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and/or poorly controlled asthma)
  • Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events/h using 4 % AHI) or high suspicion for sleep disordered breathing
  • Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.)
  • No regular sleep at night: shift work or other continuous, non-disease-related life conditions
  • Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently
  • Pregnant and/or breast-feeding
  • Ear jewelry and/or piercings that subject not willing to/unable to remove
  • Use of device/implant that may interfere with the study devices/procedures (e.g., vagal nerve stimulator)
  • Smoke and/or use of smokeless tobacco products
  • Subjects who, in the opinion of the investigator(s), may not be suitable for the study

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gabbi Montefiore contact

(480)574-1288

montefiore.gabrielle@mayo.edu

Arleth Valencia contact

(480)342-6487

Valencia.Arleth@mayo.edu

United States4 sites, 4 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Phoebe Aney, (617) 975-7568, paney@bidmc.harvard.edu

    Robert Thomas, MD

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Wesley Dillinger, (904)953-3626, dillinger.wesley@mayo.edu

    Joseph Cheung, MD

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Lupe (Ray) Canez, (480) 574-2753, Canez.Lupe@mayo.edu

    Chad Ruoff, MD

    Recruiting

  • Stanford University

    Redwood City, California, 94063

    Miran Cho, (650)503-3489, mirancho@stanford.edu

    Emmanuel Mignot, MD

    Recruiting

Other trials in United States

About this study

Official title: Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia

Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.

Being tested
Low Sodium Oxybate, 24-hour polysomnography, Nextsense EEG earbuds, Axivity device
Medical subject headings
Idiopathic Hypersomnia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Sodium OxybateDrug

    Also called Xywav, Calcium, Magnesium, Potassium, and Sodium Oxybates

    Titrated according to standard of care and continued on stable dose for 3 months

  • 24-hour polysomnographyDiagnostic test

    Performed in a sleep study lab, recording of body functions including brain activity, eye movements, muscle activity, heart rhythm and blood oxygen levels while asleep and awake for a 24-hour period

  • Nextsense EEG earbudsDevice

    Ear buds used to record sleep staging worn for a 24-hours period

  • Axivity deviceDevice

    Wristband that records activity level worn for approximately one month to track sleep and steps/activity.

Study groups in NCT05837091
Study groupRoleWhat they receive
Low Soduim Oxybate for Idiopathic HypersomniaExperimentalSubjects prescribed with low sodium oxybate for idopathic hypersomnia will have a 24-hour polysomnography, wear an Axivity wristband and Nextsense EEG earbuds to evaluate total sleep time.
Receives: Drug: Low Sodium Oxybate; Diagnostic Test: 24-hour polysomnography; Device: Nextsense EEG earbuds; Device: Axivity device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Total Sleep Time

    Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.

    Measured: Baseline, 3 months

Secondary outcomes (3)

  1. Change in total sleep time as measured by Nextsense EEG earbuds

    Measured by the Nextsense EEG earbuds reported as total minutes a participant is deemed sleeping.

    Measured: Baseline, 3 months

  2. Change in total sleep time as measured by Axivity device

    Measured by the Axivity device reported as total minutes a participant is deemed sleeping.

    Measured: Baseline, 3 months

  3. Change in total sleep time as measured by patient sleep diary

    Measured by patient sleep diary entries as total minutes a participant reported sleeping.

    Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start14 Feb 2024
  3. Primary completion29 Jan 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05837091
Sponsor's protocol ID
21-006906
Status last verified
Apr 2026
First submitted
19 Apr 2023
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low Sodium Oxybate, 24-hour polysomnography and Nextsense EEG earbuds in people with Idiopathic Hypersomnia, run by Mayo Clinic at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabbi Montefiore ((480)574-1288, montefiore.gabrielle@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Sleep Time (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05837091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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