Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

NCT05837091 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 21-006906
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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. In addition, this study will use novel tools to determine when an individual is awake or asleep.

Conditions

Idiopathic Hypersomnia

Outcome Measures

Primary Outcomes (1)

• Change in Total Sleep Time

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

  Baseline, 3 months

Secondary Outcomes (3)

• Change in total sleep time as measured by Nextsense EEG earbuds

  Baseline, 3 months

• Change in total sleep time as measured by Axivity device

  Baseline, 3 months

• Change in total sleep time as measured by patient sleep diary

  Baseline, 3 months

Study Arms (1)

Low Soduim Oxybate for Idiopathic Hypersomnia

EXPERIMENTAL

Subjects 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.

Drug: Low Sodium Oxybate; Diagnostic Test: 24-hour polysomnography; Device: Nextsense EEG earbuds; Device: Axivity device

Interventions

Low Sodium Oxybate DRUG

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

Also known as: Xywav, Calcium, Magnesium, Potassium, and Sodium Oxybates

Low Soduim Oxybate for Idiopathic Hypersomnia

24-hour polysomnography DIAGNOSTIC_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

Low Soduim Oxybate for Idiopathic Hypersomnia

Nextsense EEG earbuds DEVICE

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

Low Soduim Oxybate for Idiopathic Hypersomnia

Axivity device DEVICE

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

Low Soduim Oxybate for Idiopathic Hypersomnia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (4)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Stanford University

Redwood City, California, 94063, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Idiopathic Hypersomnia

Interventions

Calcium; Magnesium; Potassium; Polysomnography

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Metals, Light; Metals, Alkali; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Chad Ruoff, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabbi Montefiore

CONTACT

(480)574-1288; montefiore.gabrielle@mayo.edu

Arleth Valencia

CONTACT

(480)342-6487; Valencia.Arleth@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: February 14, 2024
• Primary Completion: January 29, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)