Clinical trial NCT05459272: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorders
Keywords: Sleep disorder,
Dietary supplement
Insomnia
Actigraphy
Lead sponsor: Uriach Consumer Healthcare
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Change in mean sleep latency (SL)
timeFrame: At the end of study (Day 15)
measure: Change in total sleep time (TST)
timeFrame: At the end of study (Day 15)
measure: Change in number of awakenings at night, assessed by actigraphy
timeFrame: At the end of study (Day 15)
measure: Change in distribution of sleep and awake periods throughout the day (DSW)
timeFrame: At the end of study (Day 15)
Secondary outcomes:
measure: Type of insomnia
timeFrame: At the beginning
measure: Time from insomnia onset
timeFrame: At the beginning (Day 0)
measure: Symptoms secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Lack of memory or concentration secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Fatigue o discomfort secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Day time sleepiness secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Low performance secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Lack of energy secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Headache secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Gastrointestinal symptoms secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Irritability secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Concern about sleep secundary to insomnia
timeFrame: At the beginning (Day 0)
measure: Change in Pittsburgh Sleep Quality Index (PSQI) score
timeFrame: At the end of study (Day 15)
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: At the end of study (Day 15)
measure: Change in quality of life score (SF-12)
timeFrame: At the end of study (Day 15)
measure: Change in mean sleep latency (SL) according to electronic sleep diary
timeFrame: At the end of study (Day 15)
measure: Change in number of awakenings at night, according to electronic sleep diary
timeFrame: At the end of study (Day 15)
measure: Change in total minutes awake out of bed, according to electronic sleep diary
timeFrame: At the end of study (Day 15)
measure: Change in total minutes awake intrasleep, according to electronic sleep diary
timeFrame: At the end of study (Day 15)
measure: Tolerability and safety of the product
timeFrame: At the end of study (Day 15)
measure: Compliance
timeFrame: At the end of study (Day 15)
measure: Patient satisfaction
timeFrame: At the end of study (Day 15)
Other outcomes:
Locations:
city: Alboraya
country: Spain
facility: Instituto de Medicina del Sueño
state: Valencia
Study officials:
affiliation: Principal Investigator
name: Jesús Escribá, PhD
role: PRINCIPAL_INVESTIGATOR
References: