Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality
- Conditions
- Sleep Disorders
- Interventions
- Dietary Supplement: Aquilea Sueno ForteOther: Placebo
- Registration Number
- NCT05459272
- Lead Sponsor
- Uriach Consumer Healthcare
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Aquilea Sueño Forte Aquilea Sueno Forte Patients included in this group will be administered dietary supplement with melatonin and herbal products, one tablet daily 30 min before to go to bed during 7 days (from day 7 to day 14). Control Placebo The control will consist of a placebo based on excipients without active ingredients so that the tablet has the same appearance as the test product. Patients should take one tablet daily 30 min before to go to bed during 7 days (from day 7 to day 14).
- Primary Outcome Measures
Name Time Method Change in mean sleep latency (SL) 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 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Tolerability and safety of the product At the end of study (Day 15) Number of participants with incidence of treatment-related adverse effects and adverse reaction as a Measure of Safety and Tolerability
Compliance At the end of study (Day 15) Number of days taking the treatment before going to sleep
Type of insomnia At the beginning Proportion of patients with each type of insomnia: conciliation insomnia, maintenance insomnia or mixed insomnia
Time from insomnia onset At the beginning (Day 0) Time from insomnia problems onset (weeks, months)
Symptoms secundary to insomnia At the beginning (Day 0) Mean of number of symptoms caused by insomnia: fatigue o discomfort, day time sleepiness, lack of memory or concentration, low performance, lack of energy, headache, gastrointestinal symptoms, irritability, concern about sleep.
Lack of memory or concentration secundary to insomnia At the beginning (Day 0) Percentage of patients with lack of memory or concentration caused by insomnia.
Fatigue o discomfort secundary to insomnia At the beginning (Day 0) Percentage of patients with fatigue o discomfort caused by insomnia.
Lack of energy secundary to insomnia At the beginning (Day 0) Percentage of patients with lack of energy caused by insomnia.
Headache secundary to insomnia At the beginning (Day 0) Percentage of patients with headache caused by insomnia.
Gastrointestinal symptoms secundary to insomnia At the beginning (Day 0) Percentage of patients with gastrointestinal symptoms caused by insomnia.
Day time sleepiness secundary to insomnia At the beginning (Day 0) Percentage of patients with day time sleepiness caused by insomnia.
Change in Insomnia Severity Index (ISI) score At the end of study (Day 15) Change in Insomnia Severity Index (ISI) score comparing score obtained at the beginning (day 0) and at the end of the study (day 15)
Change in quality of life score (SF-12) At the end of study (Day 15) Change in quality of life score (SF-12) comparing score obtained at the beginning (day 0) and at the end of the study (day 15)
Low performance secundary to insomnia At the beginning (Day 0) Percentage of patients with low performance caused by insomnia.
Irritability secundary to insomnia At the beginning (Day 0) Percentage of patients with irritability caused by insomnia.
Change in Pittsburgh Sleep Quality Index (PSQI) score At the end of study (Day 15) Change in PSQI score comparing score obtained at the beginning (day 0) and at the end of the study (day 15)
Change in number of awakenings at night, according to electronic sleep diary At the end of study (Day 15) Change in number of awakenings at night comparing mean SL during first week (without treatment) with mean SL during second week (with treatment), according to electronic sleep diary
Change in total minutes awake out of bed, according to electronic sleep diary At the end of study (Day 15) Change in mean of total minutes awake out of bed comparing mean of total minutes during first week (without treatment) with mean of total minutes during second week (with treatment), according to electronic sleep diary
Concern about sleep secundary to insomnia At the beginning (Day 0) Percentage of patients with concern about sleep caused by insomnia.
Change in mean sleep latency (SL) according to electronic sleep diary At the end of study (Day 15) Change in mean of SL (time it takes to fall asleep when you go to bed) comparing mean SL during first week (without treatment) with mean SL during second week (with treatment), according to electronic sleep diary
Change in total minutes awake intrasleep, according to electronic sleep diary At the end of study (Day 15) Change in mean of total minutes awake intrasleep comparing mean of total minutes during first week (without treatment) with mean of total minutes during second week (with treatment), according to electronic sleep diary
Patient satisfaction At the end of study (Day 15) Patient satisfaction on the efficacy and tolerability of treatment with the dietary supplement, using 5-point Likert scales ((0=very dissatisfied, 1=dissatisfied, 2=indifferent, 3=satisfied, 4=very satisfied)
Trial Locations
- Locations (1)
Instituto de Medicina del Sueño
🇪🇸Alboraya, Valencia, Spain