Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505447
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
PICU-related Sleep and Circadian Dysregulation Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Three-phase Pilot Study of the Feasibility of the Measurement and Promotion of Sleep and the Circadian Rhythm in a Pediatric Intensive Care Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours
Detailed Description:
Several of the identified sleep disruptors in a pediatric intensive care environment may not be modifiable including restricting feeding to daytime hours and providing normal daytime light exposure This study aims to measure the feasibility of measuring sleep and circadian patterns in a PICU during routine care and during 2 focused sleep promotion interventions timed daytime light exposure DLE and daytime feeding restriction DFR The overall objective of this study is to test the hypothesis that with multi-disciplinary efforts providing chronotherapeutic care will be feasible and that reliably measuring sleep patterns and the CR of critically ill children with timed salivary melatonin assays and actigraphy is possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None