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Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

NCT05711927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-15

Study results available
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Summary

The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are:

1. Do preterm infants who sleep in the SNOO have more quiet sleep?
2. Do preterm infants who sleep in the SNOO have improved vital signs?

* Participants will spend two separate three-hour periods sleeping in either a SNOO (which plays white noise and rocks from side-to-side) or in a SNOO that remains off (does not play white noise and does not move). There will be at least one week separating these sleep assessments.
* Participants will have their sleep stage and vital signs monitored (heart rate and oxygen levels).
* Participants will also wear two stickers on their forehead that measure brain oxygen levels (NIRS) and brain waves (EEG).

There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.

Conditions

  • Prematurity
  • Very Preterm Maturity of Infant

Interventions

DEVICE

SNOO Smart Sleeper

Infants will be secured in the SNOO Sleep Sack. They will be placed in the center of the SNOO Smart Sleeper. The SNOO will be powered on and will start playing white noise and rocking from side-to-side. The SNOO's movement and sound settings will automatically ramp up and down as needed in response to the infant's sensed level of fussiness or crying per the manufacturer's programming. The "preemie mode" will be enabled, which caps motion at level 2 out of 5.

DEVICE

Traditional bassinet

Infants will be swaddled using a standard hospital blanket. They will be placed in the center of the SNOO Smart Sleeper, but the SNOO will be left powered-off. No white noise will be played. No side-to-side rocking motions will occur.

Sponsors & Collaborators

Principal Investigators

  • Rakesh Sahni, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-16
Primary Completion
2024-05-31
Completion
2025-06-02
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05711927 on ClinicalTrials.gov