Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

August 26, 2025 updated by: Rakesh Sahni, Columbia University

The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sleep plays an important role in the brain growth and development of preterm infants. Neonatal sleep is made up of three stages of sleep: quiet sleep, active sleep, and transitional sleep. Poor sleep can be a result of premature birth itself as well as from simply being in the neonatal intensive care unit (NICU) environment. The interruptions that these infants are exposed to include frequent cares, physical exams, lights, and noises.

The investigators are interested in the potential positive effects on sleep of recreating the environment of the womb. The SNOO is a bassinet that uses the combination of a secure swaddle, white noise, and gentle rocking movements to mimic the conditions that infants were exposed to in the uterus before being born. The investigators are interested in studying how recreating this environment of "within the womb" impacts the sleep-wake cycles of premature infants. To do this, the investigators will measure the amount of time that premature infants spent asleep versus awake while in the SNOO through behavior observations, electroencephalogram (brain activity monitoring), and vital signs. The investigators hypothesize that sleeping in the SNOO will increase the amount of time that the premature infants spend in quiet sleep and will improve their vital signs.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian

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.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inpatients at the Morgan Stanley Children's Hospital NICU.
  • Singleton gestation.
  • Gestational age 28w0d to 36w6d at birth.
  • Postmenstrual age greater than 35 weeks at the time of the intervention.
  • Weight greater than 1.8 kg and less than 11.3 kg.
  • Stable thermoregulation in an open crib.
  • Stable respiratory status on room air (no nasal cannula or CPAP).
  • Normal head ultrasound (if obtained).

Exclusion Criteria:

  • Congenital brain or spinal anomalies.
  • Intracranial hemorrhage.
  • Severe encephalopathy.
  • Known or suspected genetic syndromes that could result in cerebral dysfunction.
  • Airway anomalies that could result in sleep-disordered breathing.
  • Bleeding diatheses.
  • Status post surgery or minor surgical procedures (i.e. inguinal hernia repair, circumcision).
  • Fetal opioid exposure.
  • Administration of sedating agents over the past 24 hours.
  • Ability to independently roll to hands and knees.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SNOO group
The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.
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.
Sham Comparator: Traditional bassinet group
The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Quiet Sleep Time During 3-hour Sleep Assessment
Time Frame: At baseline sleep assessment, up to 3 hours
Quiet sleep is a marker of sleep maturation and will be measured by the researcher during the 3-hour-long sleep assessments. Quiet sleep defined as eyes closed with predominantly flaccid "rag doll" appearance, body movements limited to startles, and rhythmic jaw jerks lasting 1 to 2 seconds.
At baseline sleep assessment, up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability
Time Frame: Up to 3 hours
Heart rate variability is the fluctuation of beat-to-beat heart rate intervals over time and is a marker of autonomic nervous system maturation.
Up to 3 hours
Change in Cerebral Oxygenation
Time Frame: Up to 3 hours
Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).
Up to 3 hours
Change in Oxygen Saturation
Time Frame: Up to 3 hours
Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry.
Up to 3 hours
Change in Intermittent Hypoxemic Event Frequency
Time Frame: Up to 3 hours
Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry.
Up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Happiest Baby, Inc.

Investigators

  • Principal Investigator: Rakesh Sahni, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

June 2, 2025

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU2315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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