A Randomized, Placebo-Controlled Clinical Trial on a Dietary Supplement Containing Melatonin and Herbal Products to Improve Sleep Quality in Subjects With Insomnia Problems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in mean sleep latency (SL)
研究概览
简要总结
A randomized, double-blind, placebo-controlled clinical trial on the ability of a dietary supplement containing melatonin and herbal products to improve sleep quality in subjects with insomnia problems with a 15-day follow-up period.
详细描述
This is a single-centre clinical trial on a dietary supplement with a 15-day follow-up period.
The investigators will include patients of legal age with DSM-5 diagnostic criteria for insomnia, without other sleep disorders.
The study will begin at baseline visit (day 0), when the inclusion and exclusion criteria will be confirmed and patient will sign the informed consent form. Information related to sleeping disorder will be collected and actigraphy device will be delivered to the patient. Patient will wear the device during 14 days.
After 7 days of wearing the device, patient will return to the follow-up visit (visit 1). The actigraph data will be downloaded and the treatment will be dispensed to the patient. Regimen will consist of taking one tablet per day of the product (dietary supplement or placebo) 30 minutes before bedtime during the following 7 days and will continue to wear the device.
At day 15 (final visit) patient will return the actigraph and clinical and safety data will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of legal age with DSM-5(*) diagnostic criteria for insomnia assessed from the Sleep Test responses (ST: 5-item questionnaire modified from the "Oviedo Sleep Questionnaire").
- •Patients with insomnia of the following types: sleep onset insomnia (> 30 minutes of sleep latency), maintenance insomnia (frequent awakenings or inability to fall asleep after awakening) or mixed insomnia
- •Patients who are not on treatment or have not taken any dietary supplements or hypnotics for insomnia, or any other psychoactive drug in the past week.
- •Patients able to understand the implications of the study and who demonstrate this by voluntarily signing the informed consent
- •DSM-5 diagnostic criterion for insomnia:
- •A. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
- •Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)
- •Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. (In children, this may manifest as difficulty returning to sleep without caregiver intervention.)
- •Early-morning awakening with inability to return to sleep. B. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
- •C. The sleep difficulty occurs at least 3 nights per week. D. The sleep difficulty is present for at least 3 months. E. The sleep difficulty occurs despite adequate opportunity for sleep. F. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).
- •G. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication).
- •H. Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
排除标准
- •Pregnant or nursing women
- •Patients with other sleep disorders: narcolepsy, obstructive apnea, circadian rhythm disorder, parasomnias
- •Patients with active psychiatric disorders or cognitive impairment
- •Patients with serious diseases that, in the physician's opinion, could interfere with the results of the study or disadvise their participation in it
- •Patients who do not give their written consent
- •Patients with known hypersensitivity or intolerance to any of the active ingredients or components of the dietary supplement or placebo.
结局指标
主要结局
Change in mean sleep latency (SL)
时间窗: At the end of study (Day 15)
Change in sleep latency comparing mean sleep latency during first week (without treatment) with mean sleep latency during second week (with treatment), assessed by actigraphy.
Change in number of awakenings at night, assessed by actigraphy
时间窗: At the end of study (Day 15)
Change in number of awakenings at night comparing average number of awakenings at night during first week (without treatment) with average number of awakenings at night during second week (with treatment), assessed by actigraphy.
Change in distribution of sleep and awake periods throughout the day (DSW)
时间窗: At the end of study (Day 15)
Changes in distribution of sleep and awake periods throughout the day (DSW) comparing the DSW during first week (without treatment) with DSW during second week (with treatment), assessed by actigraphy.
Change in total sleep time (TST)
时间窗: At the end of study (Day 15)
Change in total sleep time comparing mean total sleep time during first week (without treatment) with mean total sleep time during second week (with treatment), assessed by actigraphy.
次要结局
- Type of insomnia(At the beginning)
- Time from insomnia onset(At the beginning (Day 0))
- Symptoms secundary to insomnia(At the beginning (Day 0))
- Lack of memory or concentration secundary to insomnia(At the beginning (Day 0))
- Fatigue o discomfort secundary to insomnia(At the beginning (Day 0))
- Lack of energy secundary to insomnia(At the beginning (Day 0))
- Headache secundary to insomnia(At the beginning (Day 0))
- Gastrointestinal symptoms secundary to insomnia(At the beginning (Day 0))
- Day time sleepiness secundary to insomnia(At the beginning (Day 0))
- Change in Insomnia Severity Index (ISI) score(At the end of study (Day 15))
- Change in quality of life score (SF-12)(At the end of study (Day 15))
- Low performance secundary to insomnia(At the beginning (Day 0))
- Irritability secundary to insomnia(At the beginning (Day 0))
- Change in Pittsburgh Sleep Quality Index (PSQI) score(At the end of study (Day 15))
- Change in number of awakenings at night, according to electronic sleep diary(At the end of study (Day 15))
- Change in total minutes awake out of bed, according to electronic sleep diary(At the end of study (Day 15))
- Concern about sleep secundary to insomnia(At the beginning (Day 0))
- Change in mean sleep latency (SL) according to electronic sleep diary(At the end of study (Day 15))
- Change in total minutes awake intrasleep, according to electronic sleep diary(At the end of study (Day 15))
- Patient satisfaction(At the end of study (Day 15))
- Tolerability and safety of the product(At the end of study (Day 15))
- Compliance(At the end of study (Day 15))