Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality

A Randomized, Placebo-Controlled Clinical Trial on a Dietary Supplement Containing Melatonin and Herbal Products to Improve Sleep Quality in Subjects With Insomnia Problems

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.

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.

Inclusion Criteria:

• 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:

1. Difficulty initiating sleep. (In children, this may manifest as difficulty initiating sleep without caregiver intervention.)
2. 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.)
3. 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.

Exclusion Criteria:

• 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.