An interventional study of Music Therapy Entrainment with Ocean Disc Intervention in Prematurity, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 24 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Supportive care
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 120 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion Criteria:
Participants in this group will receive the ocean disc music therapy entrainment intervention
Behavioral: Music Therapy Entrainment with Ocean Disc Intervention
Participants in this group will not receive any 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.
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
Cerebral oxygen saturation measured using NIRS
Time frame: 14 days
Plan to share: No — IPD will be made available upon reasonable request to corresponding author
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Icahn School of Medicine at Mount Sinai