The SUPRA Trial for the Treatment of OSA: Design and Interim AHI and Safety Endpoints
Authors List
Kingman Strohl MD, Case Western Reserve University, Cleveland OH, USA and SUPRA Study Group
Rationale
If obstructive sleep apnea (OSA) is caused by a collapsible segment, then negative pressure applied outside this segment might improve patency in humans, as demonstrated in anesthetized dogs (Wolin et al 1990). Indeed, an external collar forming an air-tight chamber applying ~30cmH2O vacuum to the anterior neck can expand the oro- and naso-pharynx and improve Pcrit (Kato et al 2015). The hypothesis of SUPRA (Study Using Negative Pressure to
Reduce Apnea - NCT04861038) is that a self-contained collar vacuum (aerSleep® II as shown) can treat OSA.
Design
A multi-center, single-arm, prospective, observational intervention study to determine the safety and effectiveness of the aerSleep II System. Recruitment is open for this FDA pivotal trial until 79 subjects complete 6-months of at-home therapy.
Methods
Conducted at sleep centers in the United States, documented CPAP–intolerant subjects meeting eligibility (age >18 years, BMI <42, and an untreated AHI4% with >80% obstructive events by an at-home 2-night Nox T3 home sleep apnea testing (HSAT) of 15-50/hour) were fitted to one of three collar sizes. After a 7-day acclimatization trial, those that showed a >50% reduction in AHI4% to less than 20/hour (“Responders”) and accepted therapy agreed to 6 months of supervised treatment, either in-person or video conferencing. Primary 6-month endpoint of AHI4% to less than 20/hour and safety, and secondary endpoints include ODI4%, and subjective improvements by Patient Global Impression Scale (PGIS), PROMIS Sleep Disturbance, and PROMIS Sleep-related Impairment questionnaires. Reported here are interim 7-day and 6-month end-points of AHI and safety.
Results
Of screened subjects, 50% were excluded, most frequently due to baseline AHI being too high or, mostly, too low (72%). 110 subjects (59±SD11 years, 43% Female, 84% Caucasian) met study criteria; none had carotid disease by ultrasound. Following device acclimation, 28 (50%) did not meet 7-day pre-selected on-treatment AHI criteria. In 23 (41%) Responder subjects, AHI reduced from 26.6±8.5/hour to 8.1±5.6 (p=0.001), and these Responders differed from non-responders (AHI from 32.7±13.1 to 26.7±9.4, p=0.06) by a reduction in both apneas and hypopneas and ODI; the average AHI is reduced for non-responders but not by 50%. During the 6-month phase, 7 withdrew consent. In all provided collars, local irritation occurred in 29 instances in 28 participants, resolving with 1-3 days of discontinuation; and therapy was resumed. Eight have completed 6 months without safety issues, and 7 continued to exceed AHI efficacy endpoints seen after the 7-day acclimatization period.
Conclusions
An in-home testing plan and remote questionnaire collection with limited in-person contact was largely successful for assessment of eligibility and 6-month outcome. We conclude that the aerSleep II device, with current collar sizes and pressure, can reduce the AHI burden at 7 days and continues to do so for up to 6 months without major safety concerns.
Presented representing the 15 US sites and the SUPRA Reading Center. SUPRA study supported by Sommetrics Inc, San Diego, CA
Kingman Strohl MD, Case Western Reserve University, Cleveland OH, USA and SUPRA Study Group
Rationale
If obstructive sleep apnea (OSA) is caused by a collapsible segment, then negative pressure applied outside this segment might improve patency in humans, as demonstrated in anesthetized dogs (Wolin et al 1990). Indeed, an external collar forming an air-tight chamber applying ~30cmH2O vacuum to the anterior neck can expand the oro- and naso-pharynx and improve Pcrit (Kato et al 2015). The hypothesis of SUPRA (Study Using Negative Pressure to
Reduce Apnea - NCT04861038) is that a self-contained collar vacuum (aerSleep® II as shown) can treat OSA.
Design
A multi-center, single-arm, prospective, observational intervention study to determine the safety and effectiveness of the aerSleep II System. Recruitment is open for this FDA pivotal trial until 79 subjects complete 6-months of at-home therapy.
Methods
Conducted at sleep centers in the United States, documented CPAP–intolerant subjects meeting eligibility (age >18 years, BMI <42, and an untreated AHI4% with >80% obstructive events by an at-home 2-night Nox T3 home sleep apnea testing (HSAT) of 15-50/hour) were fitted to one of three collar sizes. After a 7-day acclimatization trial, those that showed a >50% reduction in AHI4% to less than 20/hour (“Responders”) and accepted therapy agreed to 6 months of supervised treatment, either in-person or video conferencing. Primary 6-month endpoint of AHI4% to less than 20/hour and safety, and secondary endpoints include ODI4%, and subjective improvements by Patient Global Impression Scale (PGIS), PROMIS Sleep Disturbance, and PROMIS Sleep-related Impairment questionnaires. Reported here are interim 7-day and 6-month end-points of AHI and safety.
Results
Of screened subjects, 50% were excluded, most frequently due to baseline AHI being too high or, mostly, too low (72%). 110 subjects (59±SD11 years, 43% Female, 84% Caucasian) met study criteria; none had carotid disease by ultrasound. Following device acclimation, 28 (50%) did not meet 7-day pre-selected on-treatment AHI criteria. In 23 (41%) Responder subjects, AHI reduced from 26.6±8.5/hour to 8.1±5.6 (p=0.001), and these Responders differed from non-responders (AHI from 32.7±13.1 to 26.7±9.4, p=0.06) by a reduction in both apneas and hypopneas and ODI; the average AHI is reduced for non-responders but not by 50%. During the 6-month phase, 7 withdrew consent. In all provided collars, local irritation occurred in 29 instances in 28 participants, resolving with 1-3 days of discontinuation; and therapy was resumed. Eight have completed 6 months without safety issues, and 7 continued to exceed AHI efficacy endpoints seen after the 7-day acclimatization period.
Conclusions
An in-home testing plan and remote questionnaire collection with limited in-person contact was largely successful for assessment of eligibility and 6-month outcome. We conclude that the aerSleep II device, with current collar sizes and pressure, can reduce the AHI burden at 7 days and continues to do so for up to 6 months without major safety concerns.
Presented representing the 15 US sites and the SUPRA Reading Center. SUPRA study supported by Sommetrics Inc, San Diego, CA
