The Function of Biphasic Sleep in Infants

NCT06399939 | Recruiting

• 1 other identifier: 4320
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Outcome Measures

Primary Outcomes (1)

• Memory accuracy

  Deferred imitation task accuracy (0-100%; higher is better memory)

  4 hours

Study Arms (2)

Nap

EXPERIMENTAL

Naps are promoted

Behavioral: Nap

Wake (non-nap)

EXPERIMENTAL

Wake is promoted

Behavioral: Wake

Interventions

Nap BEHAVIORAL

Naps are common but promoted by soothing, lying the infant down, and/or rocking and massaging

Nap

Wake BEHAVIORAL

Wake is encouraged by keeping the infant upright, providing stimulation (e.g., reading books, handing toys)

Wake (non-nap)

Eligibility Criteria

• Age: 9 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months at the time of enrollment
• normal birthweight (5.5 to 10 lbs) and gestational length (36-41 weeks)
• must be willing and able to return for testing in 3 and 6 months (e.g., no plans to move out of the area)

You may not qualify if:

• born premature (\<36 weeks gestational age)
• receiving services due to developmental delays
• visual or motor disability
• score \<85 on cognitive and language composite scales and/or \<80 on the average of the two composites of the Bayley Scales of Infant Development Fourth Edition (BSID-IV) administered at the first session.
• Infants' motor development (gross and fine motor) will also be assessed using the BSID-IV, and an adjusted cutoff of 73 will be used to exclude infants with significant motor delays (given the motoric nature of the task).
• traveling beyond 1 time zone within 2 weeks prior to testing (phone screening)
• fever or symptoms of respiratory illness at the time of testing (phone screening)
• physical handicap that interferes with assessments (vision, hearing impairment; phone screening)

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• University of Maryland, College Park: collaborator

Study Sites (1)

University of Massachusetts, Amherst

Amherst, Massachusetts, 01003, United States

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to morning or afternoon nap manipulation In each manipulation, participants complete a nap and a wake condition

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Approximately 12 months after data collection is complete, the data will be placed in Databrary which will hold it long-term (unless disrupted by technical or financial capacity)
• Access Criteria: Access to the files in Databrary will be granted to PIs at research institutions (with an IRB or similar entity) for educational or research purposes with the consent of participants and in accordance with policies of the University of Massachusetts Amherst IRB. Additionally, users of Databrary agree to (1) maintain participant confidentiality; (2) not use data for commercial use; and (3) use data consistent with the practices of their own lab, university, and local IRB.

Locations

US (1)