Recruiting

Wireless Acoustic Sensor

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT07552025

Conditions

Apnea of Prematurity

Preterm Infant

Periodic Breathing

Hypopnea

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Wireless acoustic sensor

Semi-structured interview

Nox T3s portable sleep monitoring device

Bedside monitor

Study Details

Brief summary:

Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems. These respiratory events include pauses in breathing, shallows breaths, and irregular breathing patterns. These problems are most common right after birth but can continue for weeks, leading to extended hospital stays, higher medical costs, and potential long-term health concerns affecting the eyes, lungs, and brain.

Currently, neonatal intensive care units (NICUs) use methods like measuring oxygen levels, heart rate, and electrical resistance in the chest to monitor for respiratory events. However, these methods have limitations. For instance, they cannot accurately measure airflow and do not distinguish between different types of respiratory events. As a results, some breathing problems might go unnoticed or be managed improperly.

To address this, the investigators have developed a wireless acoustic sensor that uses advanced microphones and motion sensors to record airflow and chest movements. In initial tests with healthy preterm infants, this sensor proved reliable in detecting breathing patterns and airway obstruction, suggesting it could offer a more precise and non-invasive monitoring method.

This study aims to assess how well this new sensor performs compared to existing methods in detecting and distinguishing different types of respiratory events in a high-risk group of extremely preterm infants. The investigators will track respiratory patterns in extremely preterm infants at various stages between 32 and 44 weeks of age. By comparing the new sensor's performance with currents standards and gold-standard methods, the investigators hope to improve the management of these respiratory events and reduce the related health risks.

Conditions

Apnea of Prematurity

Preterm Infant

Periodic Breathing

Hypopnea

Study ID

NCT07552025

Start date

May 28, 2026

Status verified date

May, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants with gestational age < 29+0 weeks.
  • Off respiratory support at the time of study recording.

Exclusion Criteria:

  • Infants with known major congenital anomalies.
  • Infants deemed clinically unstable for the study by the attending physician.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Extremely Preterm Infants

Infants with gestational age < 29+0 weeks and off respiratory support at the time of study recording.

Healthcare Professionals

Healthcare Professionals-including physicians, nurses, and respiratory therapists-caring for study participants.

Interventions

Wireless acoustic sensor

Airflow and respiratory effort will be measured using a single wireless acoustic sensor placed at the infant's suprasternal notch. Measurements will be performed at four postmenstrual age (PMA) intervals: 32 + 0 to 33 + 6 weeks, 34 + 0 to 36 + 6 weeks, 37 + 0 to 39 + 6 weeks, and 40 + 0 to 43 + 6 weeks. At each time point, data will be collected during a continuous 3-hour recording period with the infant positioned supine.

Semi-structured interview

A 20-minute semi-structured interview will be conducted by one trained team member with healthcare professionals to explore and assess their perspectives on the current limitations and clinical acceptance of using a wireless acoustic sensor for monitoring respiratory events in the NICU.

Nox T3s portable sleep monitoring device

Breathing efforts will be measured using two RIP bands placed around the chest and abdomen of the infant, respectively. Airflow will be measured using a nasal pressure transducer via prongs placed on the infant's nostrils. Both measurements will be obtained using a Nox T3s portable sleep monitoring device (Nox Medical, Reykjavik, Iceland). Measurements will be performed at four postmenstrual age (PMA) intervals: 32 + 0 to 33 + 6 weeks, 34 + 0 to 36 + 6 weeks, 37 + 0 to 39 + 6 weeks, and 40 + 0 to 43 + 6 weeks. At each time point, data will be collected during a continuous 3-hour recording period with the infant positioned supine.

Bedside monitor

Cardiorespiratory waveform data (TTI, SpO2, and HR) will be directly extracted from the infant's bedside monitor.

All acquired signals will be aggregated and synchronized a posteriori onto a user-friendly interface.

Primary outcome measure

  • Respiratory events [ Time Frame: At four time points, over a 3-hour period, between: (1) 32+0-33+6 weeks PMA; (2) 34+0-36+6 weeks PMA; (3) 37+0-39+6 weeks PMA; (4) 40+0-43+6 weeks PMA ]

Central Contacts and Locations

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Principal Investigator:

Wissam Shalish

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Aug 19, 2026

Last verified

May, 2026

Keywords

  • Apnea of prematurity
  • Preterm infants
  • Diagnostic accuracy study
  • Respiratory acoustics
  • Respiratory events
  • Neonatal Intensive Unit Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-08-19.