Infants with Spinal Muscular Atrophy (SMA) develop respiratory insufficiency due to progressive respiratory muscle weakness caused by degeneration of alpha motor neurons in the spinal cord. This weakness results in ineffective airway clearance which is the major cause of morbidity and mortality in infants with SMA-1.
This means that measuring longitudinal changes in respiratory muscle function in infants and young children with SMA-1 is critical to the evaluation of interventions targeting SMA-1. Many studies of infants with SMA-1 are significantly hampered due to the lack of appropriate respiratory testing tools suitable for infant use. This has resulted in many SMA-1 trials not appropriately evaluating objective measures of respiratory function.
Accurate measurement of pulmonary ventilation or breathing traditionally requires the use of devices such as masks or mouthpieces coupled to the airway opening which are unsuited to monitor infants.
As an alternative, the study referred to as the “FIREFISH Phase II Multicenter Clinical Trial for in Infants with SMA-1”. Great Lakes Neuro Technologies Inc. www.glneurotech.com is partnering with VivoSense also known as Vivonoetics www.vivonoetics.com to provide advanced respiratory assessment for the first large SMA-1 clinical trial.
The trial is going to use “Respiratory Inductance Plethysmography” (RP) systems to non-invasively sense respiratory excursions of the body. It is now going to be possible to analyze RP data to evaluate infant breathing using Vivonoetics’ VivoSense® analysis software in conjunction with trained data analysts.
RP technology will use the BioRadio® https://glneurotech.com/bioradio from Great Lakes Neuro Tech. The BioRadio ® a wireless wearable data acquisition system is capable of recording RP on infants in real-time. RP data is then wirelessly transmitted to a computer via Bluetooth and made available to the Vivonoetics team for post-collection processing and analysis.
According to Carissa Simmerman, BioRadio Clinical Trials Manager at Great Lakes Neuro Tech, “We are strongly committed to using wearable and remote monitoring technology to make a positive impact on the quality of life for those affected by respiratory disorders.”