RECRUITING

The Function of Biphasic Sleep in Infants

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Function of Biphasic Sleep in Infants

Quick Facts

Study Start:2023-09-01

Study Completion:2029-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06399939

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Months to 15 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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)	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.

Inclusion Criteria

Exclusion 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)

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.

Contacts and Locations

Study Locations (Sites)

University of Massachusetts, Amherst

Amherst, Massachusetts, 01003

United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Amherst

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01

Study Completion Date2029-01-31

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2029-01-31

Terms related to this study

Additional Relevant MeSH Terms

Sleep Deprivation