Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Change in Total Sleep Time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 24-hour polysomnography (Diagnostic Test)
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.
干预措施: Nextsense EEG earbuds (Device)
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.
干预措施: Low Sodium Oxybate (Drug)
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.
干预措施: Axivity device (Device)
结局指标
主要结局
Change in Total Sleep Time
时间窗: Baseline, 3 months
Measured by the 24-hour polysomnography reported as total minutes a participant is deemed sleeping.
次要结局
- Change in total sleep time as measured by Nextsense EEG earbuds(Baseline, 3 months)
- Change in total sleep time as measured by Axivity device(Baseline, 3 months)
- Change in total sleep time as measured by patient sleep diary(Baseline, 3 months)
研究者
Chad M. Ruoff
Principal Investigator
Mayo Clinic