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

Primary Purpose

Sleep Disorders

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Aquilea Sueno Forte

Placebo

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring Sleep disorder,, Dietary supplement, Insomnia, Actigraphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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.

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.

Sites / Locations

Instituto de Medicina del SueñoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Aquilea Sueño Forte

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Type of insomnia

Proportion of patients with each type of insomnia: conciliation insomnia, maintenance insomnia or mixed insomnia

Time from insomnia onset

Time from insomnia problems onset (weeks, months)

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.

Lack of memory or concentration secundary to insomnia

Percentage of patients with lack of memory or concentration caused by insomnia.

Fatigue o discomfort secundary to insomnia

Percentage of patients with fatigue o discomfort caused by insomnia.

Day time sleepiness secundary to insomnia

Percentage of patients with day time sleepiness caused by insomnia.

Low performance secundary to insomnia

Percentage of patients with low performance caused by insomnia.

Lack of energy secundary to insomnia

Percentage of patients with lack of energy caused by insomnia.

Headache secundary to insomnia

Percentage of patients with headache caused by insomnia.

Gastrointestinal symptoms secundary to insomnia

Percentage of patients with gastrointestinal symptoms caused by insomnia.

Irritability secundary to insomnia

Percentage of patients with irritability caused by insomnia.

Concern about sleep secundary to insomnia

Percentage of patients with concern about sleep caused by insomnia.

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)

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)

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)

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

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

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

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

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

Compliance

Number of days taking the treatment before going to sleep

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)

Full Information

NCT ID

NCT05459272

First Posted

July 11, 2022

Last Updated

August 30, 2023

Sponsor

Uriach Consumer Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT05459272

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 10, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Uriach Consumer Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorders

Keywords

Sleep disorder,, Dietary supplement, Insomnia, Actigraphy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a dietary supplement with melatonin and herbal products, with two parallel group of subjects. Once the informed consent is signed, the patient will be assigned a patient code. The study treatment will be provided in white boxes with trial and patient identification labels, which will be identical for both products (dietary supplement and placebo), and the administration regimen will be the same for both products, thereby maintaining the double blind. Treatment intake will begin on study day 7 and end on day 14. The investigator will have an encrypted randomization list, so that, if necessary, he/she can determine the treatment group assigned to a patient. Treatment compliance will be recorded by the investigator at the 14-day visit. No other pharmacological or non-pharmacological treatment for insomnia will be allowed during the study.

Masking

ParticipantCare ProviderInvestigator

Masking Description

double blind

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Aquilea Sueño Forte

Arm Type

Experimental

Arm Description

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).

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Aquilea Sueno Forte

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in mean sleep latency (SL)

Description

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.

Time Frame

At the end of study (Day 15)

Title

Change in total sleep time (TST)

Description

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.

Time Frame

At the end of study (Day 15)

Title

Change in number of awakenings at night, assessed by actigraphy

Description

Time Frame

At the end of study (Day 15)

Title

Change in distribution of sleep and awake periods throughout the day (DSW)

Description

Time Frame

At the end of study (Day 15)

Secondary Outcome Measure Information:

Title

Type of insomnia

Description

Proportion of patients with each type of insomnia: conciliation insomnia, maintenance insomnia or mixed insomnia

Time Frame

At the beginning

Title

Time from insomnia onset

Description

Time from insomnia problems onset (weeks, months)

Time Frame

At the beginning (Day 0)

Title

Symptoms secundary to insomnia

Description

Time Frame

At the beginning (Day 0)

Title

Lack of memory or concentration secundary to insomnia

Description

Percentage of patients with lack of memory or concentration caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Fatigue o discomfort secundary to insomnia

Description

Percentage of patients with fatigue o discomfort caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Day time sleepiness secundary to insomnia

Description

Percentage of patients with day time sleepiness caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Low performance secundary to insomnia

Description

Percentage of patients with low performance caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Lack of energy secundary to insomnia

Description

Percentage of patients with lack of energy caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Headache secundary to insomnia

Description

Percentage of patients with headache caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Gastrointestinal symptoms secundary to insomnia

Description

Percentage of patients with gastrointestinal symptoms caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Irritability secundary to insomnia

Description

Percentage of patients with irritability caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Concern about sleep secundary to insomnia

Description

Percentage of patients with concern about sleep caused by insomnia.

Time Frame

At the beginning (Day 0)

Title

Change in Pittsburgh Sleep Quality Index (PSQI) score

Description

Change in PSQI score comparing score obtained at the beginning (day 0) and at the end of the study (day 15)

Time Frame

At the end of study (Day 15)

Title

Change in Insomnia Severity Index (ISI) score

Description

Change in Insomnia Severity Index (ISI) score comparing score obtained at the beginning (day 0) and at the end of the study (day 15)

Time Frame

At the end of study (Day 15)

Title

Change in quality of life score (SF-12)

Description

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)

Time Frame

At the end of study (Day 15)

Title

Change in mean sleep latency (SL) according to electronic sleep diary

Description

Time Frame

At the end of study (Day 15)

Title

Change in number of awakenings at night, according to electronic sleep diary

Description

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

Time Frame

At the end of study (Day 15)

Title

Change in total minutes awake out of bed, according to electronic sleep diary

Description

Time Frame

At the end of study (Day 15)

Title

Change in total minutes awake intrasleep, according to electronic sleep diary

Description

Time Frame

At the end of study (Day 15)

Title

Tolerability and safety of the product

Description

Number of participants with incidence of treatment-related adverse effects and adverse reaction as a Measure of Safety and Tolerability

Time Frame

At the end of study (Day 15)

Title

Compliance

Description

Number of days taking the treatment before going to sleep

Time Frame

At the end of study (Day 15)

Title

Patient satisfaction

Description

Time Frame

At the end of study (Day 15)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Fortuny

Phone

+34 938 630 311

anna.fortuny@uriach.com

First Name & Middle Initial & Last Name or Official Title & Degree

Montse Vidal, PhD

Phone

+34 663825890

montsevidal@crossdata.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jesús Escribá, PhD

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Medicina del Sueño

City

Alboraya

State/Province

Valencia

ZIP/Postal Code

46120

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesus Escribá

Phone

+34644199883

idi@dormirbien.info

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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