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The Pediatric Sleep Study

5 november 2026 bijgewerkt door: Olly, PBC

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of a Dietary Gummy on Sleep Outcomes in Children Aged 4-16 With Parent/Guardian-Reported Sleep Concerns

The goal of this clinical trial is to learn if a melatonin-free sleep gummy (a chewable dietary supplement) improves sleep in children aged 4 to 16 whose parents report sleep concerns. It will also learn about the safety and tolerability of the gummy. The main questions it aims to answer are:

  1. Does the gummy improve the child's sleep disturbance, compared with a look-alike gummy?
  2. Does the gummy change daytime problems linked to poor sleep, sleep habits, and the parent's overall impression of the child's sleep?
  3. What medical problems do children have when taking the gummy?

Researchers will compare the sleep gummy to a placebo (a look-alike gummy that contains no active ingredient) to see if the sleep gummy improves sleep.

Participants will:

  1. Complete about 1 week of baseline questionnaires and diaries, then take 2 gummies once a day in the evening for 4 weeks, with a parent or guardian supervising
  2. Take part from home, with no clinic visits, using the Chloe study app
  3. Answer sleep questionnaires every week, a sleep habits questionnaire every 2 weeks, and a safety survey every week
  4. Have a parent or guardian keep a daily diary of sleep, naps, mood, activity, and the time the gummies were taken
  5. Some participants (an optional group of 60) will also wear a wrist device (a fitness tracker/smartwatch) at night to measure sleep

Studie Overzicht

Gedetailleerde beschrijving

Each family takes part for up to about 11 weeks in total which includes a 1 week baseline period and a 4 week study product/placebo use period.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • California
      • Los Angeles, California, Verenigde Staten, 90045
        • People Science, Inc.
        • Hoofdonderzoeker:
          • Noah Craft, MD, PhD
        • Contact:
        • Onderonderzoeker:
          • Marie C Erfe, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

4 jaar tot 16 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Child is aged 4 to 16 years, inclusive, at screening.
  • Parent or legal guardian reports current concerns about the child's sleep (for example, difficulty falling asleep, staying asleep, or keeping a consistent sleep routine) and confirms the child has no diagnosed sleep disorder.
  • Parent or legal guardian can read and understand English.
  • Parent or legal guardian can read, understand, and give informed consent on behalf of the child; the child gives age-appropriate assent where applicable.
  • Parent or legal guardian can use a personal smartphone and download Chloe by People Science.
  • Parent or legal guardian can receive shipment of the study product or placebo, and any wearable device, at an address within the United States.
  • Parent or legal guardian can support the child in completing study assessments for up to 11 weeks.
  • Child is willing and able to consume the gummy and can safely chew and swallow gummy products.
  • Parent or legal guardian agrees to keep the child's current lifestyle, diet, bedtime routine, and physical activity for the whole study.
  • Child has a regular sleep-wake cycle with a consistent bedtime and wake time (within about 1 hour on weekdays and weekends) for at least 3 weeks before baseline, and agrees to keep this schedule during the study.

Exclusion Criteria:

  • No personal smartphone, no internet access, or unwilling to download Chloe.
  • Child has a diagnosed sleep disorder needing medical management (for example, obstructive sleep apnea, narcolepsy, or restless leg syndrome).
  • Child snores loudly on most nights, has been seen to stop breathing, gasp, or choke during sleep, or has been referred for a sleep evaluation that is not yet complete.
  • Use of melatonin, prescription sleep medication, or other sleep aids (including over-the-counter antihistamines used for sleep and CBD or hemp products) within 28 days before screening, or expected use during the study.
  • Regular caffeine intake of more than 1 caffeinated beverage (over 110 mg) per day, or unwillingness to keep caffeine intake stable and avoid caffeine after mid-afternoon.
  • Use of a standalone magnesium supplement, or any dietary supplement marketed for sleep, stress, relaxation, mood, or focus, within 30 days before randomization or during the study. A stable-dose standard children's multivitamin is allowed.
  • Any investigational therapy within 30 days before randomization.
  • Known allergy or hypersensitivity to any study product or placebo ingredient, to Asteraceae (daisy family) plants, or to soy, egg, peanut, tree nuts, shellfish, milk, wheat, or sesame.
  • Any medical, neurodevelopmental, or psychiatric condition that, in the Principal Investigator's opinion, may confound sleep outcomes or affect participation.
  • Significant illness, disease, or condition that, in the Principal Investigator's opinion, may affect participation or outcomes.
  • Unlikely to be able to comply with the study, or considered unsuited by the Principal Investigator.
  • History or presence of a clinically diagnosed neurologic, cardiac, renal, hepatic, endocrine (including diabetes), pulmonary, biliary, or gastrointestinal condition. Well-controlled asthma managed with as-needed medication, seasonal allergies, and mild eczema are not exclusions.
  • Body mass index at or above the 95th percentile for age and sex.
  • Use of angiotensin-converting enzyme inhibitors, other magnesium-retaining drugs, or potassium-sparing diuretics.
  • Other diseases or medications that might interfere with the study or put the participant's health at risk.
  • Immune insufficiency (such as selective IgA deficiency, common variable immunodeficiency, or X-linked agammaglobulinemia).
  • Taking any prescription medication or dietary supplement for anxiety, depression, mood, stress, focus, or attention-deficit/hyperactivity disorder.
  • Known liver dysfunction.
  • Use of systemic corticosteroids or immunosuppressant drugs.
  • History of cancer within the past 5 years.
  • Planned surgery or invasive medical procedures during the study.
  • Planned travel during baseline or the use period that involves a time zone change or 2 or more consecutive nights away from the usual sleep environment.
  • Parent or legal guardian cannot communicate with the study team or complete study procedures, or child has a condition that would prevent completing assent or assessments.
  • Child or household member of an employee of People Science or the Sponsor (Unilever/Olly).
  • Pregnant or breastfeeding (self-reported).
  • Another child in the same household is already enrolled.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Active Product

Under parent/guardian supervision, participant takes 2 gummies once per evening for 4 weeks.

Melatonin-free supplement intended for children who experience mild-to-moderate sleep concerns. Contains magnesium, l-theanine, lemon balm extract, and chamomile.

Placebo-vergelijker: Placebo

Under parent/guardian supervision, participants 2 gummies oncer per evening for 4 weeks

The placebo gummy matches the study product in appearance, flavor, texture, and packaging and contains no active ingredients.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance T-Score
Tijdsspanne: Baseline and weekly through Week 4 of the product or placebo use period

Age-appropriate PROMIS Pediatric Sleep Disturbance measure covering the past 7 days, reported as a T-score. Higher scores mean more sleep disturbance.

Baseline and weekly through Week 4 of the product or placebo use period

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in PROMIS Pediatric Sleep-Related Impairment T-Score
Tijdsspanne: Baseline and weekly through Week 4 of the product or placebo use period

Age-appropriate PROMIS measure of the daytime effects of poor sleep over the past 7 days, reported as a T-score. Higher scores mean more sleep-related impairment.

Baseline and weekly through Week 4 of the product or placebo use period
Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Score
Tijdsspanne: Baseline and Weeks 2 and 4 of the product or placebo use period

Parent-completed 33-item questionnaire of children's sleep behavior. Higher total scores mean more sleep problems.

Baseline and Weeks 2 and 4 of the product or placebo use period
Parent/Guardian Global Impression of Change (PGIC-Proxy) Rating at Week 4
Tijdsspanne: Week 4 of the product or placebo use period

Single parent- or guardian-rated item on a 7-point scale from 1 (very much improved) to 7 (very much worse), comparing the child's sleep with baseline.

Week 4 of the product or placebo use period
Change from Baseline in Wearable-Derived Sleep Metrics in the Wearable Substudy
Tijdsspanne: Nightly during the baseline week and the 4-week product or placebo use period.

Objective sleep metrics collected nightly by a wrist-worn consumer wearable device in a subset of participants.

Nightly during the baseline week and the 4-week product or placebo use period.
Number of Participants with Adverse Events and Serious Adverse Events
Tijdsspanne: From the start to end of the study product/placebo use period through (Days 8-35)

Adverse events and serious adverse events reported by parents or guardians and assessed by the investigator.

From the start to end of the study product/placebo use period through (Days 8-35)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parent or Guardian Sleep Daily Diary Responses
Tijdsspanne: Daily from the baseline week through the end of the 4-week product or placebo use period.

Daily diary completed by the parent or guardian covering the child's sleep, naps, mood, activity, medication changes, and time of product administration.

Daily from the baseline week through the end of the 4-week product or placebo use period.
End-of-Study Experience Survey Responses
Tijdsspanne: Once, after completion of the Week 4 assessment

Survey about the study design, product use, product experience, and use of the study app. Responses are used to identify improvements for future participant-centered study designs.

Once, after completion of the Week 4 assessment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medewerkers

Onderzoekers

  • Hoofdonderzoeker: Noah Craft, MD, PhD, People Science, Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

9 november 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

5 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Only coded, de-identified data are delivered to the sponsor. Identifiable data are not shared with the sponsor or any third party. Any release of study data to third parties requires written approval of the Principal Investigator.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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