Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Idiopathic Hypersomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837091
• Other study ID #: 21-006906
• Status: Recruiting
• Phase: Phase 4
• Start date: February 14, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Lupe (Ray) Canez
• Phone: (480)-574-2753
• Email: Canez.Lupe[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Idiopathic Hypersomnia

Intervention

Drug:
• Low Sodium Oxybate
Titrated according to standard of care and continued on stable dose for 3 months

Diagnostic Test:
• 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

Device:
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Stanford University	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Sleep Time	Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	Change in total sleep time as measured by Axivity device	Measured by the Axivity device reported as total minutes a participant is deemed sleeping.	Baseline, 3 months
Secondary	Change in total sleep time as measured by patient sleep diary	Measured by patient sleep diary entries as total minutes a participant reported sleeping.	Baseline, 3 months