CTIS2024-514391-41-00招募中1 期
Evaluation of the Effects of Neurexan® on Short-Term Insomnia, Daytime Performance and Stress Response by Polysomnography (PSG), Electroencephalogram (EEG), Stress Biomarkers and Patient-Reported Outcomes (PROs)An Exploratory, Placebo-Controlled Trial in Short-Term Insomnia Patients - C2104
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •1. Insomnia definition according to DSM-5 criteria; episode duration less than 3 months 2. Short-term insomnia with moderate symptoms according to ISI of at least 8 and below 22 being present for at least one week, but no longer than 3 months prior to Screening Visit 3. Reports habitual bedtime, defined as the time the participant attempts to sleep, between 21:00 and 01:00 4. Reports regular time spent in bed, either sleeping or trying to sleep, between 6 and 9 hours 5. =18 years of age, not older than 65 years 6. Legally competent male or female patient 7. Signed Informed Consent 8. Females of childbearing potential must agree to maintain highly effective or acceptable birth control throughout the trial (CTFG 2020). Highly effective (failure rate of less than 1% per year) • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable • Intrauterine device • Intrauterine hormone-releasing system • Bilateral tubal occlusion • Vasectomized partner (provided partner is sole sexual partner and if vasectomized partner has received medical assessment of the surgical success) • Sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with investigational treatment) Acceptable birth control methods which may not be considered as highly effective (failure rate of more than 1% per year) • Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action • Male or female condom with or without spermicide • Cap, diaphragm or sponge with spermicide • Combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) 9. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 at Screening Visit 10. Use of digital device e.g., smartphone, tablet or laptop 11. German speaking and reading.
排除标准
- •1. Patients with insomnia symptoms present longer than 90 days prior to Screening Visit 2. Based on the diagnostic interview, reported history (within 2 years) of other sleep disorders (e.g., chronic insomnia, circadian rhythm sleep disorders, restless legs syndrome (RLS), obstructive sleep apnea (OSA)), i.e., STOPBang (SBQ) questionnaire score =5, International Restless Legs Scale score =16) 3. Based on the first polysomnographic screening night at Baseline 1, insomnia due to sleep apnea or periodic limb movement disorder (PLMD): OSA (Apnea Hypopnea Index of >5 events/ hour), PLMD (Periodic Limb Movement Index (PLMI) >15 events/ hour) 4. Rotating shift work with overnight shifts 5. History of psychiatric disorders within the last 6 months prior to Screening Visit according to the Structured Clinical Interview for DSM-5® Disorders – Clinician Version (SCID-5-CV) 6. History of sensitivity to any component of Neurexan® 7. Unwilling or unable to comply with all the requirements of the clinical trial protocol 8. Cognitive impairment (cut-off of 24 points in the Montreal Cognitive Assessment [MoCA]; Thomann, Berres et al. 2020) at Screening Visit 9. Any history of or current abuse of alcohol and/or amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opioids, propoxyphene, barbiturates, phencyclidine; or expected to take during trial participation (urine drug screening at Screening Visit and adaptation nights) 10. Current use of medication affecting sleep, i.e., antidepressants, antipsychotics, diuretics, blood pressure drugs, anti-dementia drugs (e.g., piracetam), herbal and homeopathic medicine, hormone preparations (e.g., thyroxine) with the exception of hormonal contraceptives 11. Use of Neurexan® within the last two weeks from Screening Visit 12. Non-pharmacological insomnia therapies (e.g., cognitive behavioral therapy within the last 6 months of Screening Visit, sleep restriction therapy, complementary and alternative therapies as meditation, Traditional Chinese Medicine, aromatherapy) 13. Excessive consumption of xanthine-containing beverages (more than 7 cups daily of coffee or tea or other beverages containing xanthines) 14. Use of nicotine during the last 6 months prior to Screening Visit 15. Participation in any interventional clinical study within the past 30 days prior to Screening Visit 16. Any relationship of dependence with the Sponsor or with the Investigator 17. Active infection/ disease (C-Reactive Protein [CRP] >5 mg/l) 18. Hypertension defined as systolic blood pressure =140 mmHg (Burnier, 2018) 19. History of neurological, rheumatic, chronic pain, immune, cardiovascular, pulmonary, liver/ kidney, or metabolic disorder within the last 6 months prior to Screening Visit 20. Nocturia 21. Pregnancy (as proven by positive urine pregnancy test at Screening Visit) or breastfeeding 22. Patients with moderate to severe skin allergies and/or eczema 23. Raynaud's disease 24. Donation of blood or platelets 3 months prior to or in-between in-hospital visits.
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