Rhinomed Ltd, an Australian company focused on the development of nasal and respiratory technologies, has received Monash Health Human Research Ethics Committee (HREC) approval for its inaugural Phase 1 sleep apnea trial featuring its new intranasal positive expiratory airway pressure (INPEAP) technology.
- Ethics approval granted for PHASE 1 pilot study of novel Intranasal Positive Expiratory Airway Pressure (INPEAP) device to treat moderate obstructive sleep apnea (OSA).
- Total of 20 moderate OSA patients to be enrolled in a polysomnography in-clinic study and 14 day in-home tolerance trial.
- The primary endpoint to confirm that moderate OSA is attenuated (through EPAP) with the Rhinomed INPEAP device.
- Results expected late 2015 and anticipated to add to evidence that a well-tolerated intranasal device can radically change adoption of, and compliance with, OSA treatment.
Rhinomed’s INPEAP technology is being developed as a potential new therapy for the US$13 billion dollar OSA market. According to the seminal Wisconsin Sleep Cohort Study, moderate OSA represents 70% of all sleep apnea patients.
Rhinomed CEO, Michael Johnson, says in a release: “This is a pivotal moment for Rhinomed. The work carried out establishing the Turbine in sport and exercise and Mute in the OTC snoring space continues to socialize people with the idea of using a nasal stent. The INPEAP technology leverages this acceptance of a nasal solution and seeks to address the appalling compliance rates that currently exist in the OSA market.”
The trial will be conducted at the Monash Lung and Sleep Department, Monash Health.