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The Pediatric Sleep Study

5 de noviembre de 2026 actualizado por: 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

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • California
      • Los Angeles, California, Estados Unidos, 90045
        • People Science, Inc.
        • Investigador principal:
          • Noah Craft, MD, PhD
        • Contacto:
        • Sub-Investigador:
          • Marie C Erfe, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

4 años a 16 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

Comparador de placebos: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance T-Score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in PROMIS Pediatric Sleep-Related Impairment T-Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Parent or Guardian Sleep Daily Diary Responses
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Noah Craft, MD, PhD, People Science, Inc.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

9 de noviembre de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

5 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Publicado por primera vez (Actual)

12 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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