Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:47 PM
Study NCT ID:
NCT07420504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood
Sponsor:
Children's Hospital of Soochow University
Organization:
Study Overview
Official Title:
Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SuSleep
Brief Summary:
The global incidence of mental illness among children and adolescents is rising, drawing increasing attention to early risk factors and preventive strategies. Behavioral sleep problems, which affect up to 50% of infants in the local population, are closely linked to impaired self-regulation-a core factor underlying many psychological disorders and a promising target for early intervention. Enhancing self-regulation may not only alleviate sleep problems but also mitigate long-term mental health risks. This study aims to develop an intervention toolkit based on current guidelines and high-quality evidence, integrating parent education with dynamic sleep assessment and longitudinal evaluation of self-regulation in infants. The project seeks to establish the efficacy of this approach, identify moderators of intervention outcomes, and provide an evidence base for personalized sleep interventions in clinical practice.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: