Trial Outcomes & Findings for Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants (NCT NCT05711927)

NCT ID: NCT05711927

Last Updated: 2025-09-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

At baseline sleep assessment, up to 3 hours

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	SNOO Group The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.	Traditional Bassinet Group The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SNOO Group n=11 Participants The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.	Traditional Bassinet Group n=9 Participants The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.	Total n=20 Participants Total of all reporting groups
Age, Continuous	32.9 weeks STANDARD_DEVIATION 1.9 • n=5 Participants	33.5 weeks STANDARD_DEVIATION 1.4 • n=7 Participants	33.1 weeks STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline sleep assessment, up to 3 hours

Outcome measures

Outcome measures
Measure	SNOO Group n=11 Participants The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.	Traditional Bassinet Group n=9 Participants The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.
Percent of Quiet Sleep Time During 3-hour Sleep Assessment	26.8 percent Standard Deviation 9.5	19.8 percent Standard Deviation 5.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 hours

Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 hours

Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 hours

Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry.

Outcome measures

Outcome data not reported

Adverse Events

SNOO Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Bassinet Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Toni Iurcotta, MD

Columbia University Irving Medical Center

Phone: 646-532-8196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place