← Back to Search

Behavioral Intervention

Sleep Promotion Intervention for Childhood Sleep Issues

N/A
Waitlist Available
Led By Ayesha Sania, Sc.D.
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Study Summary

This trial tests a 3-week behavior sleep intervention for 2-3 year old children in Bangladesh to improve their sleep health.

Who is the study for?
This trial is for healthy children aged 2-3 years who attend early learning centers. It's not suitable for kids with cerebral palsy, severe developmental delays, cardiac disease, autism or those born preterm or with low birthweight.Check my eligibility
What is being tested?
The study tests a behavioral sleep intervention called 'Adapted Sleep Well, Bee Well' over three weeks to see if it helps improve sleep in preschoolers compared to children who are on a wait-list at two Early Learning Centers in Dhaka, Bangladesh.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on improving sleep habits and routines without the use of medication, no direct side effects are anticipated as part of the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Parental knowledge and beliefs about children's sleep
Intervention feasibility and acceptability
Secondary outcome measures
Change in Bedtime Routine
Change in Bedtime Variability
Change in Children's Sleep Duration Variability
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Parent questionnaires and sleep characteristics of children (actigraphy and parent report) will be collected at three-time points- Time 1, 2, and 3. Time 1 is the first Baseline Data Collection for the Control Group and Intervention Group, and these data will be collected before the intervention group starts the 3-week intervention. Between Time 1 and Time 2, the Intervention Group will receive the 3-week intervention at the childcare center.
Group II: ControlActive Control1 Intervention
The control arm will not receive the intervention. They will be assessed at time 1 and again at 2, following the completion of intervention in the intervention arm

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,847 Total Patients Enrolled
International Centre for Diarrhoeal Disease Research, BangladeshOTHER
299 Previous Clinical Trials
1,388,469 Total Patients Enrolled
Fogarty International Center of the National Institute of HealthNIH
127 Previous Clinical Trials
162,758 Total Patients Enrolled

Media Library

Adapted Sleep Well, Bee Well (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05763030 — N/A
Childhood Sleep Research Study Groups: Intervention, Control
Childhood Sleep Clinical Trial 2023: Adapted Sleep Well, Bee Well Highlights & Side Effects. Trial Name: NCT05763030 — N/A
Adapted Sleep Well, Bee Well (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763030 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research team permit participants below 30 years old to join this trial?

"In line with the specified requirements for this investigation, participants must be between 2 and 3 years old."

Answered by AI

To whom is this medical experiment available?

"To be eligible for this sleep study, participants must have an infant aged 2-3 years old. The trial is recruiting a total of 60 infants."

Answered by AI

What aim does this trial strive to accomplish?

"The primary assessment of this 21-day trial is the Change in Parental knowledge and beliefs about children's sleep. Secondary outcomes include a Change in Bedtime Variability, measured with successive differences via Actiwatch 2 data; an increase in Children's Sleep Duration as tracked by their Respironics Actiwatch AW2 accelerometer; and increased stability of that duration through improved Night-to-night variability (MSSD) again captured by the actigraphs. All variables are scored using the Actiware software before being processed and submitted to statisticians for analysis."

Answered by AI

Are any recruitment initiatives underway for this clinical research?

"According to clinicaltrials.gov, the study is not currently enrolling patients; this trial was initially posted on April 1st 2027 and last updated February 28th of 2023. Nevertheless, there are other medical studies searching for volunteer participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sleep Promotion Intervention in Bangladesh
Ayesha Sania 2027. "Sleep Promotion Intervention in Bangladesh". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763030.
~40 spots leftby Apr 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top