This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA. The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
117
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Sleep Med Inc., AZ
Glendale, Arizona, United States
Sleep Disorders at Magnolia Park
Gainesville, Florida, United States
Adherence (minutes of device use per night)
Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
Time frame: 6 week
Apnea-Hypopnea Index (AHI, events/hr)
Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
Time frame: 6 week
Epworth Sleepiness Scale (ESS)
SPT vs. APAP
Time frame: 6 week
Functional Outcomes of Sleep Questionnaire (FOSQ)
SPT vs. APAP
Time frame: 6 week
SF-36
SPT vs. APAP
Time frame: 6 week
Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)
SPT vs. APAP
Time frame: 6 week
Oxygen Desaturation Index (3%)
SPT vs. APAP
Time frame: 6 week
Total Sleep Time (minutes)
SPT vs. APAP (measured by in lab polysomnography)
Time frame: 6 week
Sleep Onset Latency (minutes)
SPT vs. APAP (measured by in lab polysomnography)
Time frame: 6 week
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Kentucky Research Group
Louisville, Kentucky, United States
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Luke's Sleep Medicine and Research Center
Chesterfield, Missouri, United States
Clayton Sleep Institute
Maplewood, Missouri, United States
Med One Sleep
Fayetteville, North Carolina, United States
Pearl Clinical Research
Paoli, Pennsylvania, United States
...and 1 more locations
Sleep Efficiency (%)
SPT vs. APAP (measured by in lab polysomnography)
Time frame: 6 week
Arousal Index
SPT vs. APAP (measured by in lab polysomnography)
Time frame: 6 week
Sleep Stages (%)
SPT vs. APAP (measured by in lab polysomnography)
Time frame: 6 week
Sleep Position (%)
SPT vs. APAP (measured by in lab polysomnography)
Time frame: 6 week
Mean Disease Alleviation (MDA) (%)
SPT vs. APAP (MDA (%) is calculated by the product of the objective adherence (from SPT and APAP download), adjusted for total sleep time (X-axis), combined with therapeutic efficacy (AHI from the respective treatment night, Y-axis), divided by 100.)
Time frame: 6 weeks
Adverse Events
SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.
Time frame: 6 weeks