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

NCT05459272 | Unknown

• 1 other identifier: URI-AQ-SUEFORT-2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Keywords

Sleep disorder,; Dietary supplement; Insomnia; Actigraphy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (22)

• Type of insomnia

  At the beginning

• Time from insomnia onset

  At the beginning (Day 0)

• Symptoms secundary to insomnia

  At the beginning (Day 0)

• Lack of memory or concentration secundary to insomnia

  At the beginning (Day 0)

• Fatigue o discomfort secundary to insomnia

  At the beginning (Day 0)

Study Arms (2)

Experimental: Aquilea Sueño Forte

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Aquilea Sueno Forte DIETARY_SUPPLEMENT

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).

Experimental: Aquilea Sueño Forte

Placebo OTHER

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).

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uriach Consumer Healthcare: lead

Study Sites (1)

Instituto de Medicina del Sueño

Alboraya, Valencia, 46120, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Jesús Escribá, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Fortuny

CONTACT

+34 938 630 311; anna.fortuny@uriach.com

Montse Vidal, PhD

CONTACT

+34 663825890; montsevidal@crossdata.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: July 10, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)