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NCT05130229 · ClinicalTrials.gov registry record · NA
Community Partnership for Healthy Sleep: Sleep Well, Bee Well Part 2
A NA study of Pediatric Sleep, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 98
- Enrollment target
- 2
- Study locations
NCT05130229: Completed NA study of Pediatric Sleep, sponsored by Yale University.
NCT05130229 is a NA study of Pediatric Sleep that has completed, run by Yale University. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05130229, a NA study of Pediatric Sleep, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
- 2
- Study locations
Study Summary
Using a pragmatic cluster randomized trial, this study aims to examine the feasibility, and acceptability of a 3-week behavioral sleep intervention, Sleep Well, Bee Well (SWBW), and to test the preliminary efficacy of SWBW compared to a wait-list control with children ages 1-2.5 years old at two Early Head Start (EHS) centers on toddler sleep characteristics and parent wellbeing.
Primary Outcome
The bedtime sleep characteristics will be measured with the Respironics Actiwatch AW2, an accelerometer placed on the toddler's ankle. Reliability for actigraphy in toddlers ranges from .67-.85 when measuring sleep duration. The toddlers will wear the water resistant Actiwatch 2 for seven 24-hour periods at Time 1, 2, and 3. The investigators hypothesize that SWBW will improve toddlers' objectively measured bedtime (goal: bedtime before 9:00PM or at least 45 minutes earlier from baseline). Actig
Conditions Studied
Interventions
- BEHAVIORAL Sleep Well Bee Well
Study Locations (2)
Connecticut
- Lulac Head Start, Inc. - New Haven
- West Haven Child Development Center - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2022-10-31 |
| Phase | NA |
What the finished NCT05130229 record still lists
NCT05130229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Pediatric Sleep appearing as the primary indexed condition, and to 1 intervention - of which Sleep Well Bee Well is the first listed.
NCT05130229 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05130229 about?
NCT05130229 is a clinical study titled "Community Partnership for Healthy Sleep: Sleep Well, Bee Well Part 2". Using a pragmatic cluster randomized trial, this study aims to examine the feasibility, and acceptability of a 3-week behavioral sleep intervention, Sleep Well, Bee Well (SWBW), and to test the preliminary efficacy of SWBW compared to a wait-list control with children ages 1-2.5 years old at two Ear...
What is the current status of trial NCT05130229?
This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2022-03-08. Estimated completion is 2022-10-31.
What conditions does trial NCT05130229 study?
This clinical trial studies the following conditions: Pediatric Sleep.
What interventions are being tested in trial NCT05130229?
The interventions under investigation include: Sleep Well Bee Well (BEHAVIORAL).
Who is sponsoring clinical trial NCT05130229?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05130229 being conducted?
This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05130229's enrollment target sits among peer trials
98 922nd of 2000 higher than 1,078 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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