Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
NCT ID: NCT05837091
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2024-02-14
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Low Soduim Oxybate for Idiopathic Hypersomnia
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.
Low Sodium Oxybate
Titrated according to standard of care and continued on stable dose for 3 months
24-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
Nextsense EEG earbuds
Ear buds used to record sleep staging worn for a 24-hours period
Axivity device
Wristband that records activity level worn for approximately one month to track sleep and steps/activity.
Interventions
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Low Sodium Oxybate
Titrated according to standard of care and continued on stable dose for 3 months
24-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
Nextsense EEG earbuds
Ear buds used to record sleep staging worn for a 24-hours period
Axivity device
Wristband that records activity level worn for approximately one month to track sleep and steps/activity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects aged 18 - 65 years
3. BMI between 18 and 35 kg/m2
4. Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries
5. Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)
6. 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.
7. Subject must be willing to postpone LSO therapy until all baseline assessments completed
8. 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
9. 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 Criteria
2. Other central nervous system diseases: neurodegenerative diseases, , seizure disorders or history of head trauma associated with loss of consciousness
3. 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
4. Change to psychiatric medication(s)/stimulant(s) within last 3 months
5. History of chronic alcohol or drug abuse within the prior 12 months
6. Malignant neoplastic disease requiring therapy within the prior 12 months
7. Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study
8. Renal or hepatic impairment
9. Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and/or poorly controlled asthma)
10. Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events/h using 4 % AHI) or high suspicion for sleep disordered breathing
11. Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.)
12. No regular sleep at night: shift work or other continuous, non-disease-related life conditions
13. Participation in another study of an investigational drug within the 28 days prior to Screening visit or currently
14. Pregnant and/or breast-feeding
15. Ear jewelry and/or piercings that subject not willing to/unable to remove
16. Use of device/implant that may interfere with the study devices/procedures (e.g., vagal nerve stimulator)
17. Smoke and/or use of smokeless tobacco products
18. Subjects who, in the opinion of the investigator(s), may not be suitable for the study
18 Years
65 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Chad M. Ruoff
Principal Investigator
Principal Investigators
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Chad Ruoff, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Stanford University
Redwood City, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-006906
Identifier Type: -
Identifier Source: org_study_id
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