Ignite Creation Date:
2024-05-11 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399939
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-01
Brief Title:
The Function of Biphasic Sleep in Infants
Sponsor:
University of Massachusetts Amherst
Organization:
University of Massachusetts Amherst
Study Overview
Official Title:
The Function of Biphasic Sleep in Infants
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study is designed to investigate developmental changes in naps and nap function on memory from 9 to 15 months of age Memory is measured by a task in which the experimenter interacts with a toy and the measure of memory is whether the child imitates that action when given the toy Sleep is assessed with a watch that detects motion which provides an estimate of sleep and a set of electrodes placed on the head that measures brain activity during sleep Infants are recruited at 9 months and sleep and memory are measured again 3- and 6-months later At each visit memory is tested before and after a nap either the morning or afternoon nap and naps are recorded with the sleep electrodes
Detailed Description:
Four days prior to the first session an experimenter will meet the caregiver and infant at the lab or at their home to review procedures and complete the informed consent process The infant will be fitted with the actigraph watch on the ankle The caregiver will be given instructions on use of the actigraph watch and be left with questionnaires to complete eg sleep diary behavioral questionnaires Four days later the caregiver and infant will come to the sleep lab for their initial session In wave 1 9 months caregiver-infant dyads will be scheduled to arrive 1 hr prior to the infants typical morning nap time In later waves if the infant is reported to have eliminated their morning nap they will be scheduled to arrive 1 hr prior to when the nap typically occurred before they transitioned out of the morning nap Infants will be semi-randomly assigned to either the nap or wake condition Following acclimation to the lab the infant will be fitted with the polysomnography electrode cap The infant will then complete the encoding and immediate recall phases of the deferred imitation memory task The infant will then be either wake or nap promoted or allowed to follow their normal morning routine Approximately 90 mins later following nap waking and time to recover from sleep inertia the deferred imitation task recall will take place
The caregiver and infant will then have free time lunch playtime with instructions to return to the lab if they choose to leave they are also offered access to the lab kitchen and lounge area 40 mins before the infants typical afternoon nap They will also be instructed to 1 avoid letting the infant nap and report any sleep that occurred this will also be monitored with actigraphy 2 not partake in any unusually stimulating activities and 3 to follow a routine feeding schedule during this time When the dyad returns to the lab the infant will again be equipped with the polysomnography cap and complete the encoding and immediate recall phases with a new set of items The infant will then either be wake or nap promoted or allowed to follow their normal afternoon nap routine Approximately 90 mins later following nap and time to recover from sleep inertia the delayed recall phase will take place The infant and caregiver will return to the lab one week later to complete the other condition The procedures will be repeated at 12 12 months and 13 months and 15 months 15 months and 16 months
The caregiver and infant will then have free time lunch playtime with instructions to return to the lab if they choose to leave they are also offered access to the lab kitchen and lounge area 40 mins before the infants typical afternoon nap They will also be instructed to 1 avoid letting the infant nap and report any sleep that occurred this will also be monitored with actigraphy 2 not partake in any unusually stimulating activities and 3 to follow a routine feeding schedule during this time When the dyad returns to the lab the infant will again be equipped with the polysomnography cap and complete the encoding and immediate recall phases with a new set of items The infant will then either be wake or nap promoted or allowed to follow their normal afternoon nap routine Approximately 90 mins later following nap and time to recover from sleep inertia the delayed recall phase will take place The infant and caregiver will return to the lab one week later to complete the other condition The procedures will be repeated at 12 12 months and 13 months and 15 months 15 months and 16 months
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