ISRCTN60603080已完成Unknown
Double-blind placebo-controlled clinical study to evaluate the effect of supplementation with ETAZEO during 4 weeks in improving sleep quality in healthy Asian adults suffering from insomnia
INNOVATION LABO Sciences Co., Ltd0 个研究点目标入组 40 人开始时间: 2024年6月27日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Healthy non-smoker Asian male and female subjects between 25-65 years old (inclusive)
- •2. Presence of chronic disturbed sleep (PSQI >5)
- •3. Presence of chronic snoring. A patient is considered a chronic snorer if his/her bedmate/roommate reported snoring more than 5 days per week and if this is corroborated by medical analysis performed in the patient’s own home. The result of the respiratory polygraphy should indicate the presence of snoring during at least 30% of the nocturnal period.
- •4. Have a regular roommate or bedmate to submit information
- •5. Subjects available during the whole period of study (1 month)
排除标准
- •1. Subjects with sleep apnoea
- •2. High-risk professions and/or controlling dangerous machines
- •3. Moderate or severe somnolence during day time
- •4. Coronary cardiopathy, acute vascular disease (less than three months), chronic and severe obstructive pulmonary disease, and chronic treatment with theophyllines
- •5. Temporo-mandibular joint problems or periodontitis
- •6. Mandibular protrusion capacity less than 6 mm and/or less than 10 teeth in each jaw
- •7. Severe cognitive disorders and/or patients whose answers to the questionnaires will be altered by chronic and severe diseases
- •8. Pregnancy (since the third month of pregnancy to 3 months after birth delivery)
- •9. Patients on prolonged medication(more than 6 weeks) with sleep medication, corticosteroids, antidepressants, anticholinergics, antipsychotic drugs, etc. or any other drugs that may have an influence on the outcome of the study
- •10. Pregnant/lactating women
- •11. Subjects who cannot agree to refrain from alcohol consumption during the study period
- •12. Alcoholics and/or drug abusers
- •13. Subjects having history of psychiatric disorders that may impair the ability to provide written informed consent
- •14. Patients who have completed participation in any other clinical trials during the past 3 months
- •15. Any other conditions that the Principal Investigator thinks may jeopardize the study outcomes
研究者
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