Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Change in Total Sleep Time [Time frame: Baseline, 3 months]

Secondary outcome measures (3)

• Change in total sleep time as measured by Nextsense EEG earbuds [Time frame: Baseline, 3 months]
• Change in total sleep time as measured by Axivity device [Time frame: Baseline, 3 months]
• Change in total sleep time as measured by patient sleep diary [Time frame: Baseline, 3 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• Mayo Clinic Arizona — Phoenix
• Stanford University — Redwood City
• Mayo Clinic Florida — Jacksonville
• Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT05837091 · 21-006906

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗