Sleep DisordersNCT05459272
Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep Quality
A study testing Aquilea Sueno Forte in people with Sleep Disorders, run by Uriach Consumer Healthcare at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Aquilea Sueno Forte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
Show all 12Show fewer
- 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.
- 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).
- The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication).
- Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Instituto de Medicina del Sueño
Alboraya, Valencia, 46120
Jesus Escribá, +34644199883, idi@dormirbien.info
About this study
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
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.
Read the 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.
- Conditions
- Sleep Disorders
- Being tested
- Aquilea Sueno Forte, Placebo
- Keywords
- Sleep disorder,, Dietary supplement, Insomnia, Actigraphy
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquilea Sueno ForteDietary 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).
PlaceboOther
Also called Control
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of study (Day 15)
Secondary outcomes (22)
Type of insomnia
Proportion of patients with each type of insomnia: conciliation insomnia, maintenance insomnia or mixed insomnia
Measured: At the beginning
Time from insomnia onset
Time from insomnia problems onset (weeks, months)
Measured: 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.
Measured: 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.
Measured: At the beginning (Day 0)
Fatigue o discomfort secundary to insomnia
Percentage of patients with fatigue o discomfort caused by insomnia.
Measured: At the beginning (Day 0)
Day time sleepiness secundary to insomnia
Percentage of patients with day time sleepiness caused by insomnia.
Measured: At the beginning (Day 0)
Low performance secundary to insomnia
Percentage of patients with low performance caused by insomnia.
Measured: At the beginning (Day 0)
Lack of energy secundary to insomnia
Percentage of patients with lack of energy caused by insomnia.
Measured: At the beginning (Day 0)
Headache secundary to insomnia
Percentage of patients with headache caused by insomnia.
Measured: At the beginning (Day 0)
Gastrointestinal symptoms secundary to insomnia
Percentage of patients with gastrointestinal symptoms caused by insomnia.
Measured: At the beginning (Day 0)
Irritability secundary to insomnia
Percentage of patients with irritability caused by insomnia.
Measured: At the beginning (Day 0)
Concern about sleep secundary to insomnia
Percentage of patients with concern about sleep caused by insomnia.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of study (Day 15)
Compliance
Number of days taking the treatment before going to sleep
Measured: 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)
Measured: At the end of study (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start10 Jul 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uriach Consumer Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jesús Escribá, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459272
- Sponsor's protocol ID
- URI-AQ-SUEFORT-2021
- Status last verified
- May 2023
- First submitted
- 11 Jul 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05459272
- Acronym / sponsor ID
- URI-AQ-SUEFORT-2021
- Conditions
- Sleep Disorders
- Keywords
- Sleep disorder,, Dietary supplement, Insomnia, Actigraphy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uriach Consumer HealthcareIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Aquilea Sueño Forte | Experimental | Dietary Supplement: Aquilea Sueno FortePatients 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 comparator | Other: PlaceboThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquilea Sueno ForteThe 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). | Dietary supplement | Experimental: Aquilea Sueño Forte |
| PlaceboAlso: ControlThe 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 | Control |
Primary outcome
Change in mean sleep latency (SL)
Time frame: 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 total sleep time (TST)
Time frame: 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.
Change in number of awakenings at night, assessed by actigraphy
Time frame: 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)
Time frame: 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.
22 secondary outcomes
Type of insomnia
Time frame: At the beginning
Time from insomnia onset
Time frame: At the beginning (Day 0)
Symptoms secundary to insomnia
Time frame: At the beginning (Day 0)
Lack of memory or concentration secundary to insomnia
Time frame: At the beginning (Day 0)
Fatigue o discomfort secundary to insomnia
Time frame: At the beginning (Day 0)
Day time sleepiness secundary to insomnia
Time frame: At the beginning (Day 0)
Low performance secundary to insomnia
Time frame: At the beginning (Day 0)
Lack of energy secundary to insomnia
Time frame: At the beginning (Day 0)
Headache secundary to insomnia
Time frame: At the beginning (Day 0)
Gastrointestinal symptoms secundary to insomnia
Time frame: At the beginning (Day 0)
Irritability secundary to insomnia
Time frame: At the beginning (Day 0)
Concern about sleep secundary to insomnia
Time frame: At the beginning (Day 0)
Change in Pittsburgh Sleep Quality Index (PSQI) score
Time frame: At the end of study (Day 15)
Change in Insomnia Severity Index (ISI) score
Time frame: At the end of study (Day 15)
Change in quality of life score (SF-12)
Time frame: At the end of study (Day 15)
Change in mean sleep latency (SL) according to electronic sleep diary
Time frame: At the end of study (Day 15)
Change in number of awakenings at night, according to electronic sleep diary
Time frame: At the end of study (Day 15)
Change in total minutes awake out of bed, according to electronic sleep diary
Time frame: At the end of study (Day 15)
Change in total minutes awake intrasleep, according to electronic sleep diary
Time frame: At the end of study (Day 15)
Tolerability and safety of the product
Time frame: At the end of study (Day 15)
Compliance
Time frame: At the end of study (Day 15)
Patient satisfaction
Time frame: At the end of study (Day 15)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús Escribá, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquilea Sueno Forte in people with Sleep Disorders, run by Uriach Consumer Healthcare at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Fortuny (+34 938 630 311, anna.fortuny@uriach.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean sleep latency (SL) (time frame: At the end of study (Day 15)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.