Clinical trial NCT05837091: Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Official title: Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Idiopathic Hypersomnia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Sleep Time
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in total sleep time as measured by Nextsense EEG earbuds
timeFrame: Baseline, 3 months
measure: Change in total sleep time as measured by Axivity device
timeFrame: Baseline, 3 months
measure: Change in total sleep time as measured by patient sleep diary
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Mayo Clinic
name: Chad Ruoff, MD
role: PRINCIPAL_INVESTIGATOR
References: