Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Phase 4

Recruiting

• Conditions: Idiopathic Hypersomnia
• Interventions: Drug: Low Sodium Oxybate; Diagnostic Test: 24-hour polysomnography; Device: Nextsense EEG earbuds; Device: Axivity device

• Registration Number: NCT05837091
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-05-01
• Study Start: 2024-02-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)
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.

Read More

Exclusion Criteria

1. Succinic semialdehyde dehydrogenase deficiency, porphyria
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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Soduim Oxybate for Idiopathic Hypersomnia	Low Sodium Oxybate	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 Soduim Oxybate for Idiopathic Hypersomnia	24-hour polysomnography	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 Soduim Oxybate for Idiopathic Hypersomnia	Nextsense EEG earbuds	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 Soduim Oxybate for Idiopathic Hypersomnia	Axivity device	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.

Primary Outcome Measures

Name	Time	Method
Change in Total Sleep Time	Baseline, 3 months	Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.

Secondary Outcome Measures

Name	Time	Method
Change in total sleep time as measured by Nextsense EEG earbuds	Baseline, 3 months	Measured by the Nextsense EEG earbuds reported as total minutes a participant is deemed sleeping.
Change in total sleep time as measured by Axivity device	Baseline, 3 months	Measured by the Axivity device reported as total minutes a participant is deemed sleeping.
Change in total sleep time as measured by patient sleep diary	Baseline, 3 months	Measured by patient sleep diary entries as total minutes a participant reported sleeping.

Trial Locations

Locations (4)

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