SleepFlexTM Treatment of Obstructive Sleep Apnea
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Berendo Scientific, LLC

SleepFlex™ Treatment of Obstructive Sleep Apnea  
June 15, 2023 
NCT04726514 
 
Study Protocol (Summary) 
Study participants with mild to moderate obstructive sleep apnea (OSA) underwent 12 weeks of active 
treatment with the SleepFlex™ program of head and neck exercises. 
 
Statistical analysis includes paired t-tests to evaluate primary and exploratory outcomes in participants 
who completed the study. 
 
Results Summary 
Enrolled participants: 10 
Participants with data for analysis: 7 
 
Outcomes are presented as baseline vs. 12-week measures 
Total AHI: 15.5±5.1 vs. 12.2±5.5 events/hour (p=0.11) 
Supine AHI: 21.0±10.8 vs. 15.3±6.0 events/hour (p=0.048) 
Non-supine AHI: 7.3±7.4 vs. 6.8±6.7 events/hour (p=0.064)  
 
Maximal inspiratory pressure: 93±35 vs. 114±34 kPa (p=0.02) 
Maximal expiratory pressure: 108±33 vs. 137±14 kPa (p=0.04) 
Anterior tongue strength: 53±13 vs. 56±10 kPa (p=0.20)