Pilot Open Non-Comparative Study To Evaluate In Special Care Setting The Administration Of A New Nutraceutical Associated With Sleep Hygiene Guidelines In Subjects Affected By Persistent Mild Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pre-sleep arousal scale (PSAS);
研究概览
简要总结
The Research Hypothesis for the present pilot study in a special care setting is that in a population suffering of mild and recent sleep disorders the pre-sleep arousal measured by the Pre-Sleep Arousal Scale (PSAS) after 30 days of oral administration with a nutraceutical composed of hawthorn, lavender and hop (Sonidor®) shall significantly improve in comparison with the baseline condition.
详细描述
Sonidor® was developed as a nutraceutical composed of hawthorn, lavender and hop inducing sleep and relaxation in subjects with mild sleep disturbances. In addition, the Sonidor® innovative three-layer-tablet formulation should allow the active components to be released with different speeds into the gastrointestinal tract exerting a synergistic action to induce sleep-promoting effects.
Primary objective is to have a preliminary evaluation of the efficacy of Sonidor® in subjects affected by persistent mild sleep disorders (difficulty in initiating sleep for at least 1 month and reduced quality of sleeping) to whom in special care setting have been suggested sleep hygiene guidelines and administered the tested nutraceutical for one month.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, aged 18 to 70 years with persistent, recent (at least 1 month) and mild sleep disorders related to pre-sleep arousal and reduced quality of sleeping;
- •PSAS at baseline between 16 and 24;
- •ISI at baseline ≥ 12;
- •Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;
- •Capable of and freely willing to provide written informed consent prior to participating in the study;
排除标准
- •l. Subjects with Morningness-Eveningness Questionnaire Self-Assessment (MEQSA) values between 16 and 41;
- •Pregnancy and/or breast-feeding;
- •Subjects assuming beta blockers, hypnotic or sedative drugs or other nutraceuticals;
- •Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt, or suicidal ideation, or any other psychiatric illness (with the exception of intermittent anxiety);
- •Known intolerance to the tested product or at one of the ingredients (hawthorn, lavender or hop);
- •Drug or alcohol abuse within 12 months of Day 0;
- •All clinical conditions that, at the evaluation of the Investigator, can be referred to as secondary insomnia;
- •Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days;
- •Presence of any clinically significant medical condition judged by the investigator to preclude the subject's inclusion in the study;
研究组 & 干预措施
Sonidor®
Application: following the summary of product characteristics (l tablet per day) At the 7-day phone call the Investigator can increase the dosage to 2 tablets per day only in non-responding subjects.
干预措施: Sonidor® (Dietary Supplement)
结局指标
主要结局
Pre-sleep arousal scale (PSAS);
时间窗: 30 days
Change in Pre-sleep arousal scale PSAS from a maxim of 24 to a minimum of 16 is a positive outcome for the investigational product
次要结局
- Cognitive subscale of Pre-sleep arousal scale (PSAS)(30 days)
- Somatic subscale of PSAS (Pre-sleep arousal scale)(30 days)
- Global Assessment of Safety(30 days)
- Insomnia Severity Index (ISI)(30 days)
- Patient Health Questionnaire QoL (PHQ-9)(30 days)
- Restorative Sleep Questionnaire-Daily (RSQ-D)(30 days)