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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorders
• Intervention / Treatment: Dietary supplement: Aquilea Sueno Forte; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Fortuny; Phone Number: +34 938 630 311; Email: anna.fortuny@uriach.com
• Study Contact Backup: Name: Montse Vidal, PhD; Phone Number: +34 663825890; Email: montsevidal@crossdata.es

Study Locations

• Spain
  • Valencia
    • Alboraya, Valencia, Spain, 46120
      • Recruiting
      • Instituto de Medicina del Sueño
      • Contact: Jesus Escribá; Phone Number: +34644199883; Email: idi@dormirbien.info

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Aquilea Sueño 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).	Dietary supplement: Aquilea Sueno Forte; The test product consists of a dietary supplement in the form of tablets with three layers containing: melatonin (1.95 mg/tablet) and herbal products (extracts from Griffonia, Passiflora, California poppy, Valerian, Melissa). Patients should take one tablet daily 30 min before go to bed during 7 days (from day 7 to day 14).
Placebo Comparator: Control; 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).	Other: Placebo; The placebo will consist of tablets with three layers and with the same appearance as the dietary supplement under study, but containing no active ingredients. Patients should take one tablet daily 30 min before go to bed during 7 days (from day 7 to day 14).; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean sleep latency (SL)	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.	At the end of study (Day 15)
Change in total sleep time (TST)	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.	At the end of study (Day 15)
Change in number of awakenings at night, assessed by actigraphy	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.	At the end of study (Day 15)
Change in distribution of sleep and awake periods throughout the day (DSW)	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.	At the end of study (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of insomnia	Proportion of patients with each type of insomnia: conciliation insomnia, maintenance insomnia or mixed insomnia	At the beginning
Time from insomnia onset	Time from insomnia problems onset (weeks, months)	At the beginning (Day 0)
Symptoms secundary to insomnia	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.	At the beginning (Day 0)
Lack of memory or concentration secundary to insomnia	Percentage of patients with lack of memory or concentration caused by insomnia.	At the beginning (Day 0)
Fatigue o discomfort secundary to insomnia	Percentage of patients with fatigue o discomfort caused by insomnia.	At the beginning (Day 0)
Day time sleepiness secundary to insomnia	Percentage of patients with day time sleepiness caused by insomnia.	At the beginning (Day 0)
Low performance secundary to insomnia	Percentage of patients with low performance caused by insomnia.	At the beginning (Day 0)
Lack of energy secundary to insomnia	Percentage of patients with lack of energy caused by insomnia.	At the beginning (Day 0)
Headache secundary to insomnia	Percentage of patients with headache caused by insomnia.	At the beginning (Day 0)
Gastrointestinal symptoms secundary to insomnia	Percentage of patients with gastrointestinal symptoms caused by insomnia.	At the beginning (Day 0)
Irritability secundary to insomnia	Percentage of patients with irritability caused by insomnia.	At the beginning (Day 0)
Concern about sleep secundary to insomnia	Percentage of patients with concern about sleep caused by insomnia.	At the beginning (Day 0)
Change in Pittsburgh Sleep Quality Index (PSQI) score	Change in PSQI score comparing score obtained at the beginning (day 0) and at the end of the study (day 15)	At the end of study (Day 15)
Change in Insomnia Severity Index (ISI) score	Change in Insomnia Severity Index (ISI) score comparing score obtained at the beginning (day 0) and at the end of the study (day 15)	At the end of study (Day 15)
Change in quality of life score (SF-12)	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)	At the end of study (Day 15)
Change in mean sleep latency (SL) according to electronic sleep diary	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	At the end of study (Day 15)
Change in number of awakenings at night, according to electronic sleep diary	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	At the end of study (Day 15)
Change in total minutes awake out of bed, according to electronic sleep diary	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	At the end of study (Day 15)
Change in total minutes awake intrasleep, according to electronic sleep diary	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	At the end of study (Day 15)
Tolerability and safety of the product	Number of participants with incidence of treatment-related adverse effects and adverse reaction as a Measure of Safety and Tolerability	At the end of study (Day 15)
Compliance	Number of days taking the treatment before going to sleep	At the end of study (Day 15)
Patient satisfaction	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)	At the end of study (Day 15)

Collaborators and Investigators

• Sponsor: Uriach Consumer Healthcare
• Investigators: Principal Investigator: Jesús Escribá, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Dietary supplement; Insomnia; Actigraphy; Sleep disorder,
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: URI-AQ-SUEFORT-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No