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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to SPT First: APAP Second | Experimental | Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment. |
|
| Randomized to APAP First: SPT Second | Experimental | Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NightBalance Sleep Position Trainer (SPT) | Device | Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence (minutes of device use per night) | Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night) | 6 week |
| Apnea-Hypopnea Index (AHI, events/hr) | Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography) | 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale (ESS) | SPT vs. APAP | 6 week |
| Functional Outcomes of Sleep Questionnaire (FOSQ) | SPT vs. APAP | 6 week |
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Inclusion Criteria:
Subject is between the ages of 20 and 80.
Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening):
Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Berry, MD | UF Health Sleep Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Sleep Med Inc., AZ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31383231 | Derived | Berry RB, Uhles ML, Abaluck BK, Winslow DH, Schweitzer PK, Gaskins RA Jr, Doekel RC Jr, Emsellem HA. NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Jul 15;15(7):947-956. doi: 10.5664/jcsm.7868. |
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6 week crossover study, randomized to order of treatment
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The technician scoring the polysomnograms will be unaware of previous PSG results from the patient to the best of their ability (ie: will not look back in their records for the purpose of reviewing their previous PSGs prior to scoring).
| Automated Adjusting Positive Airway Pressure (APAP) | Device | Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG. |
|
| SF-36 | SPT vs. APAP | 6 week |
| Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS) | SPT vs. APAP | 6 week |
| Oxygen Desaturation Index (3%) | SPT vs. APAP | 6 week |
| Total Sleep Time (minutes) | SPT vs. APAP (measured by in lab polysomnography) | 6 week |
| Sleep Onset Latency (minutes) | SPT vs. APAP (measured by in lab polysomnography) | 6 week |
| Sleep Efficiency (%) | SPT vs. APAP (measured by in lab polysomnography) | 6 week |
| Arousal Index | SPT vs. APAP (measured by in lab polysomnography) | 6 week |
| Sleep Stages (%) | SPT vs. APAP (measured by in lab polysomnography) | 6 week |
| Sleep Position (%) | SPT vs. APAP (measured by in lab polysomnography) | 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.) | 6 weeks |
| Adverse Events | SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized. | 6 weeks |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Sleep Disorders at Magnolia Park | Gainesville | Florida | 32606 | United States |
| Kentucky Research Group | Louisville | Kentucky | 40218 | United States |
| Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| St. Luke's Sleep Medicine and Research Center | Chesterfield | Missouri | 63017 | United States |
| Clayton Sleep Institute | Maplewood | Missouri | 63143 | United States |
| Med One Sleep | Fayetteville | North Carolina | 28304 | United States |
| Pearl Clinical Research | Paoli | Pennsylvania | 19301 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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