Recruiting

Observational Study

Sponsor:

University of Massachusetts, Amherst

Code:

NCT06399939

Conditions

Sleep Deprivation

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Nap

Wake

Study Details

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

Study ID

NCT06399939

Start date

Sep 1, 2023

Status verified date

May, 2024

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 9 months at the time of enrollment
2. normal birthweight (5.5 to 10 lbs) and gestational length (36-41 weeks)
3. must be willing and able to return for testing in 3 and 6 months (e.g., no plans to move out of the area)

Exclusion Criteria:

1. born premature (<36 weeks gestational age)
2. receiving services due to developmental delays
3. visual or motor disability
4. 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.
5. 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).
6. traveling beyond 1 time zone within 2 weeks prior to testing (phone screening)
7. fever or symptoms of respiratory illness at the time of testing (phone screening)
8. physical handicap that interferes with assessments (vision, hearing impairment; phone screening)
9. history of neurological injury such as history of seizures, brain tumor, or stroke (phone screening) Parents/guardians of potential participants will be contacted via phone and/or email, at which time the details of the study will be specified and inclusion/exclusion criteria will be reviewed.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Nap

Naps are promoted

experimental: Wake (non-nap)

Wake is promoted

Interventions

Nap

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

Wake

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

Primary outcome measure

  • Memory accuracy [ Time Frame: 4 hours ]

Central Contacts and Locations

Locations

University of Massachusetts, Amherst

Recruiting

Amherst, Massachusetts, United States, 01003

Contacts

More Information

Sponsor

University of Massachusetts, Amherst

Last update posted

May 8, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Amherst on 2024-05-08.