MedTrace Logo

Sleep Device Testing to Promote Sleep in Infants

NCT05078112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-10-15

Study results available
· View outcomes & findings →

Summary

Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.

Conditions

  • Insomnia Chronic

Interventions

DEVICE

Sleep sensor technology

Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.

Sponsors & Collaborators

Principal Investigators

  • Sujay Kansagra, MD · Duke

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078112 on ClinicalTrials.gov