Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256887
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
Sleep Spindles Organization as an Early Neural Marker of Neuromotor Outcome
Sponsor:
IRCCS Fondazione Stella Maris
Organization:
IRCCS Fondazione Stella Maris
Study Overview
Official Title:
SONNO - Sleep Spindles Organization as an Early Neural Marker of Neuromotor Outcome a New Fast Safe Cost-effective and Infant-friendly EEG Tool to Monitor Early Sensory-motor Function in Infants at Risk of Neuromotor Disorders
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
SONNO
Brief Summary:
The goal of this observational study is to test the effectiveness of quantitative early biomarkers in the sleep electroencephalogram EEG namely sleep spindles as predictors of early sensorimotor maturation and long-term motor outcome Spindles are discrete events prominent over sensorimotor areas that reflect motor learning overnight consolidation They represent a potential marker for the investigation of altered early sensorimotor reorganization and long-term motor outcomes in the case of neuromotor pathologies To test this hypothesis we will validate the prognostic accuracy of a semi-automated EEG sleep-spindles analysis in two clinical populations 1 infants with a perinatal brain lesion at risk of Cerebral Palsy CP 2 infants with Spinal muscular atrophy type 1 SMA1 a neuromuscular disease detectable at birth with variable response to early pharmacological treatment A group of typically developing infants at very low neurological risk will be enrolled in the study as control group All participants will undergo two sleep EEG recordings at 2-5 months T1 and 12 months T2 respectively Short-term neuromotor outcome will be evaluated at T1 and T2 through standard and validated assessment Long-term neuromotor development will be defined at 18 months T3 ie CP vs NO CP SMA treatment responders vs No responders Primary clinical and motor outcomes will be used for estimating the effectiveness of spindles features at T1 and T2 as predictors of later clinical and motor outcomes at T3 EEG sleep features will be considered both cross-sectionally at each time point T1 and T2 and from a longitudinal perspective Differences in the EEG sleep-spindle features will be evaluated within- and between-groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None