Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Pediatric Sleep Study | ClinicalTrials.gov |
| NCT number | NCT07932938 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Olly, PBC | ClinicalTrials.gov |
| Conditions | Sleep Quality, Sleep and Circadian Problems | ClinicalTrials.gov |
| Interventions | Olly melatonin-free supplement, Placebo Supplement | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance T-Score | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in PROMIS Pediatric Sleep-Related Impairment T-Score | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Score | 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. | ClinicalTrials.gov |
| Secondary | Parent/Guardian Global Impression of Change (PGIC-Proxy) Rating at Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Wearable-Derived Sleep Metrics in the Wearable Substudy | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants with Adverse Events and Serious Adverse Events | 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. | ClinicalTrials.gov |
| Other | Parent or Guardian Sleep Daily Diary Responses | 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. | ClinicalTrials.gov |
| Other | End-of-Study Experience Survey Responses | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)