- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07932938
The Pediatric Sleep Study
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:
- Does the gummy improve the child's sleep disturbance, compared with a look-alike gummy?
- Does the gummy change daytime problems linked to poor sleep, sleep habits, and the parent's overall impression of the child's sleep?
- 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:
- 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
- Take part from home, with no clinic visits, using the Chloe study app
- Answer sleep questionnaires every week, a sleep habits questionnaire every 2 weeks, and a safety survey every week
- Have a parent or guardian keep a daily diary of sleep, naps, mood, activity, and the time the gummies were taken
- Some participants (an optional group of 60) will also wear a wrist device (a fitness tracker/smartwatch) at night to measure sleep
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clinical Research Study Team
- Numéro de téléphone: 213-342-5681
- E-mail: ps60pediatricsleep@peoplescience.health
Lieux d'étude
-
-
California
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Los Angeles, California, États-Unis, 90045
- People Science, Inc.
-
Chercheur principal:
- Noah Craft, MD, PhD
-
Contact:
- People Science Study Team
- Numéro de téléphone: 213-342-5681
- E-mail: ps60pediatricsleep@peoplescience.health
-
Sous-enquêteur:
- Marie C Erfe, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
|
Comparateur placebo: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance T-Score
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in PROMIS Pediatric Sleep-Related Impairment T-Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parent or Guardian Sleep Daily Diary Responses
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Noah Craft, MD, PhD, People Science, Inc.
Publications et liens utiles
Publications générales
- Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
- Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK109825/
- Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OLY-KDS-0008
- PS60 (Autre identifiant: People Science)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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