Australia-based nasal and respiratory technology company Rhinomed announced Phase I Pilot clinical trial results that support the continued development of its INPEAP (intra nasal positive expiratory air pressure) technology as a low-cost frontline treatment for moderate obstructive sleep apnea (OSA).
Rhinomed’s INPEAP technology utilizes an internally applied nasal dilator and expiratory pressure valve designed to stent the anterior nasal airway and deliver positive expiratory airway pressure, while allowing near normal inspiratory flow. The device is contoured and lined, which Rhinomed says enables superior comfort and durability.
The Phase 1 Pilot trial (n=19) conducted at the Lung and Sleep Institute, Monash Health, under principal investigator and associate professor Darren Mansfield, PhD, consisted of both an in-clinic study using polysomnography and a 14-day in-home tolerance trial.
The trial indicated that moderate-severity OSA may be attenuated through EPAP (expiratory positive air pressure), with seven patients meeting the primary end point responding positively with a 50% or more reduction in their apnea-hypopnea index (AHI) using the Rhinomed INPEAP device, five subjects were partial responders, obtaining an AHI reduction of 30%-50%, and seven did not see an improvement or had a deterioration in their AHI scores.
Four of these seven who did not see an improvement or whose AHI scores deteriorated were recorded to have significantly mouth-breathed across the night, leading to inefficient intranasal pressures and making it difficult to assess the device. Mouth breathing was not identified in any of the positive responders.
The cohort consisted of 19 healthy subjects with moderate OSA (AHI 15-29). The secondary endpoint of device tolerability was 75% with four subjects unable to tolerate using the device for the fourteen days of the trial. Comfort was cited as the most common reason for poor tolerance of this device. The INPEAP device used in the trial was a 3-D printed early stage prototype.
Subjective assessments of snoring and sleep by bed partners showed a modest reduction in snoring severity, and there was a reported increase in self-assessed sleep time (6.14 to 6.38 hours with INPEAP). The mean AHI reduced non significantly from 19.2/hr to 16.5/hr. Similar non-significant reductions were demonstrated in supine sleep (AHI 35.2/hr to 30.9/hr) and REM sleep (AHI 22.0 to 17.5/hr). Lateral AHI increased from 7.7/hr to 11.2/hr.
The results of this Phase 1 Pilot Trial support Rhinomed’s belief that a well-tolerated and low-cost intranasal device could provide a viable and effective treatment for some people with moderate OSA.
Mansfield says in a release: “These preliminary results show this device assists some patients with moderate obstructive sleep apnea with mouth breathing being a limitation for others. Better identification of solutions for mouth breathing will enhance the effectiveness of this treatment. In addition, evaluation of efficacy in more severe subsets of OSA will be of interest.”
Mouth breathing is recognized a common OSA therapy issue, and Rhinomed envisions that the inclusion of a chin-strap into the trial design and protocol may resolve this issue in future trials.
Rhinomed intends to continue materials and product design refinement of its INPEAP device and is finalizing the appointment of a scientific advisory committee to help scope further work in this area.
Preliminary data on the trial was presented in a scientific poster by the investigators at the SLEEP 2016 conference in Denver.