Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05223192

Conditions

Prematurity

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Music Therapy Entrainment with Ocean Disc Intervention

Study Details

Brief summary:

Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.

Conditions

Prematurity

Study ID

NCT05223192

Start date

Apr 1, 2022

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
  • Newborn is considered appropriate for clinically indicated music therapy

Exclusion Criteria:

  • Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)
  • Infant of uncertain viability (gestation <23 weeks, birth weight <500 grams)
  • Known or suspected genetic disorder (e.g., Trisomy 21)
  • Identified hearing disorder

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention group

Participants in this group will receive the ocean disc music therapy entrainment intervention

no intervention: Control group

Participants in this group will not receive any intervention

Interventions

Music Therapy Entrainment with Ocean Disc Intervention

The studied intervention regards live entrainment with the ocean disc. Entrainment involves the use of an external stimulus, in the case of this study, an ocean disc instrument. Motion of the disc creates sounds in synchrony with the breathing of the infant and then in turn can control and influence the infant's regulation of the breath.

Primary outcome measure

  • Heart Rate [ Time Frame: 14 days ]
  • Respiratory Rate [ Time Frame: 14 days ]
  • Oxygen-Saturation Level [ Time Frame: 14 days ]
  • Weight [ Time Frame: 14 days ]
  • Cerebral oxygen saturation [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospitals

Recruiting

New York, New York, United States, 10003

Contacts

Joanne V Loewy, DA, LCAT, MT-BC

(212) 420-3484joanne.loewy@mountsinai.org

Principal Investigator:

Joanne V Loewy

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • music therapy
  • ocean disc
  • prematurity
  • vital signs
  • cerebral oxygenation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-08-13.