NL-OMON56089尚未招募不适用
international Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (iSPHYNCS): Dutch participation - iSPHYNCS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16 至 64（—）
入选标准
- •All participants:
- •- Age 16-70 years
- •- Ability and consent to undergo electrophysiological routine assessment
- •- Ability to give informed consent
- •- Subjective complaints of excessive daytime sleepiness (EDS) and/or
- •hypersomnolence (H) as defined in the protocol
- •- EDS and/or H present daily or almost daily for at least 1 month prior to the
- •consultation
- •Healthy Controls:
- •- Proportionally age and gender matched healthy subjects
排除标准
- •All participants:
- •- Chronic infectious diseases (such as Hepatitis B/C, HIV)
- •- Chronic use of antibiotics
- •- Recent use (over 8 weeks) of immune-modulating drugs
- •- The following disorders/conditions that on clinical grounds are considered to
- •be the cause of EDS/H:
- •-- Other sleep disorders
- •-- Other neurological disorders
- •-- (Auto-)immune and systemic disorders
- •-- Malignancy (except: Status in Remission for over 10 years)
- •-- Instable psychiatric disorder
- •-- Active infectious disease at screening
- •-- Permanent medications/drugs
- •- Sleep disordered breathing (SDB): Presence of clinically significant and
- •untreated obstructive (OSA) or central sleep apnea (CSA) as determined by the
- •investigator or documented previously; or documentation of one of the
- •-- Apnea index (AI) over10 if on OSA treatment or untreated; or
- •-- Clinically significant hypoventilation; or
- •-- Noncompliance with primary OSA/PAP therapy in case of clinically
- •significant OSA
- •-- except if NTI has been diagnosed including decreased or missing CSF
- •Healthy Controls:
- •- Subjective complaints of EDS and/or H as defined in the protocol
- •- Epworth Sleepines Scale (ESS) over 10
- •- Polysomnography (PSG) with apnea index (AI) over10/h and/or periodic leg
- •movement series (PLMS) Index over 30/h
- •- SDB: Presence of clinically significant and untreated OSA or central sleep
- •apnea (CSA) as determined by the investigator or documented previously; or
- •documentation of one of the following:
- •-- Apnea index (AI) over 10 if on OSA treatment or untreated; or
- •-- Clinically significant hypoventilation; or
- •-- Noncompliance with primary OSA/PAP therapy
研究者
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