NCT04330963招募中不适用
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up
研究概览
简要总结
Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.
详细描述
An exploratory prospective, national, multi-center cohort study on clinical, electrophysiological and biological biomarkers of disease presentation and course.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participants:
- •Subjective complaints of Excessive daytime sleepiness (EDS) and/or Hypersomnia (H) as defined above
- •EDS and/or H present daily or almost daily for at least 1 month prior to the consultation
- •Ability and consent to undergo electrophysiological routine assessment
- •Ability to give informed consent
- •Healthy controls:
- •Age and gender matched healthy subjects
- •Including blood related relatives of study participants
- •Ability and consent to undergo electrophysiological routine assessment
- •Ability to give informed consent
- •Controls with Sleep disordered breathing (SDB):
- •Subjective complaints of EDS with Epworth Sleepiness Scale (ESS) > 10 (adults) and/or H due to SDB: Presence of clinically significant and untreated obstructive sleep apnea (OSA) as determined by the investigator with an apnea-hypopnea-index >30/h
- •Multiple sleep-latency test (MSLT) mean sleep latency ≤ 8min
- •Subjective and objective improvement of EDS and/or H within 3 months after treatment with
- •Positive airway pressure (PAP) therapy with documented
- •Reduction of apnea-hypopnea index below <10/h
- •Reduction of ESS by ≥ 25%
- •MSLT mean Sleep Latency > 12min
- •Ability and consent to undergo electrophysiological routine assessment
- •Ability to give informed consent
排除标准
- •Study participants and controls:
- •SDB for study participants and healthy controls: Presence of clinically significant and untreated obstructive sleep apnea (OSA) or central sleep apnea (CSA) as determined by the investigator or documented previously; or documentation of one of the following:
- •Apnea index (AI) > 10 if on OSA treatment or untreated; or
- •Clinically significant hypoventilation; or
- •Noncompliance with primary OSA therapy
- •except if NT1 has been diagnosed including decreased or missing cerebrospinal fluid (CSF) hypocretin
- •SDB for control population with SDB:
- •Central Sleep Apnea (CSA)
- •Noncompliance with primary OSA therapy and/or
- •No reported improvement of EDS and/or H within 3 months of positive airway pressure (PAP) treatment
- •The following disorders/conditions that on clinical grounds are considered to be the cause of EDS / H
- •Other sleep disorders (e.g. Restless legs syndrome (RLS) with periodic leg movement syndrome (PLMS), sleepwalking, clear-cut circadian disorder)
- •Other neurological disorders (e.g. stroke, multiple sclerosis, parkinsonism, severe traumatic brain injury)
- •(Auto-)immune and systemic disorders (such as Hashimoto Thyroiditis, Chron's Disease, ulcerous colitis, Diabetes mellitus type I, Systemic lupus erythematosus)
- •Malignancy (except: Status in Remission for at least > 10 years)
- •Instable psychiatric disorder (e.g. acute psychotic, acute suicidal, episode of major depression requiring in-hospital treatment, active substance abuse)
- •Active infectious disease at screening
- •Permanent medications / drugs
- •Chronic infectious diseases (such as Hepatitis B/C, HIV)
- •Chronic use of antibiotics
- •Recent use (< 8 weeks) of immune-modulating drugs
- •Healthy controls additional:
- •Subjective complaints of EDS and / or H
- •ESS > 10
- •Polysomnography (PSG) with AI > 10/h and / or PLMS Index > 30/h
- •MSLT mean Sleep Latency < 12 min
结局指标
主要结局
Proportion of study subjects with diagnosis of Narcolepsy type 1 (NT1) at follow up
时间窗: 36 months
Proportion of study subjects with final diagnosis other than NT1 but within the group of CDH at follow up
时间窗: 36 months
次要结局
- Proportion of patients with autoreactive T-cell clones in NT1 and some Narcolepsy borderland (NBL) subjects but not in controls(36 months)
- Preptidomic profile of NT1 and NBL in comparison to controls(36 months)
- Gut microbiome of NT1 and NBL in comparison to controls(36 months)
研究者
研究点 (1)
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