RecruitingPhase 4NCT05837091

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

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

Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Feb 14, 2024

Study Type

INTERVENTIONAL

Conditions

Idiopathic Hypersomnia

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

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.

Exclusion Criteria18

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
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

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Interventions

DRUGLow Sodium Oxybate

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

DIAGNOSTIC_TEST24-hour polysomnography

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

DEVICENextsense EEG earbuds

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

DEVICEAxivity device

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