The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
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ClinicalTrials.gov Identifier: NCT03061071 |
Recruitment Status :
Completed
First Posted : February 23, 2017
Last Update Posted : August 21, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea Syndromes | Device: NightBalance Sleep Position Trainer (SPT) Device: Automated Adjusting Positive Airway Pressure (APAP) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 117 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 6 week crossover study, randomized to order of treatment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | 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). |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Crossover Study of the NightBalance Sleep Position Trainer (SPT) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA) |
Actual Study Start Date : | March 1, 2017 |
Actual Primary Completion Date : | July 12, 2018 |
Actual Study Completion Date : | July 12, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Randomized to SPT First: APAP Second
Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment.
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Device: NightBalance Sleep Position Trainer (SPT)
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG. Device: Automated Adjusting Positive Airway Pressure (APAP) Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG. |
Experimental: Randomized to APAP First: SPT Second
Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment.
|
Device: NightBalance Sleep Position Trainer (SPT)
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG. Device: Automated Adjusting Positive Airway Pressure (APAP) Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG. |
- Adherence (minutes of device use per night) [ Time Frame: 6 week ]Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
- Apnea-Hypopnea Index (AHI, events/hr) [ Time Frame: 6 week ]Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
- Epworth Sleepiness Scale (ESS) [ Time Frame: 6 week ]SPT vs. APAP
- Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 6 week ]SPT vs. APAP
- SF-36 [ Time Frame: 6 week ]SPT vs. APAP
- Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS) [ Time Frame: 6 week ]SPT vs. APAP
- Oxygen Desaturation Index (3%) [ Time Frame: 6 week ]SPT vs. APAP
- Total Sleep Time (minutes) [ Time Frame: 6 week ]SPT vs. APAP (measured by in lab polysomnography)
- Sleep Onset Latency (minutes) [ Time Frame: 6 week ]SPT vs. APAP (measured by in lab polysomnography)
- Sleep Efficiency (%) [ Time Frame: 6 week ]SPT vs. APAP (measured by in lab polysomnography)
- Arousal Index [ Time Frame: 6 week ]SPT vs. APAP (measured by in lab polysomnography)
- Sleep Stages (%) [ Time Frame: 6 week ]SPT vs. APAP (measured by in lab polysomnography)
- Sleep Position (%) [ Time Frame: 6 week ]SPT vs. APAP (measured by in lab polysomnography)
- Mean Disease Alleviation (MDA) (%) [ Time Frame: 6 weeks ]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.)
- Adverse Events [ Time Frame: 6 weeks ]SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is between the ages of 20 and 80.
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Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening):
- Total AHI >15, or AHI >10 and <15 with ESS >10
- Supine AHI at least twice the non-supine AHI
- Non-supine AHI <10 (<5 in mild patients)
- Supine time >40% and <60%
- Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Exclusion Criteria:
- Prior surgery to treat OSA (such as UPPP), or prior or current therapy or treatment for OSA, with the exception of PAP being used for split night PSG only.
- A female of child-bearing potential that is pregnant or intends to become pregnant.
- Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, or at the discretion of the site Principal Investigator (PI).
- Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
- Oxygen use.
- The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy).
- Excessive alcohol consumption (>21 drinks/week).
- The use of any illegal drug(s).
- Night or rotating shift work.
- Severe claustrophobia.
- Shoulder, neck, or back complaints that restrict sleeping position.
- Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061071
United States, Alabama | |
Sleep Disorders Center of Alabama | |
Birmingham, Alabama, United States, 35213 | |
United States, Arizona | |
Sleep Med Inc., AZ | |
Glendale, Arizona, United States, 85306 | |
United States, Florida | |
Sleep Disorders at Magnolia Park | |
Gainesville, Florida, United States, 32606 | |
United States, Kentucky | |
Kentucky Research Group | |
Louisville, Kentucky, United States, 40218 | |
United States, Maryland | |
Center for Sleep and Wake Disorders | |
Chevy Chase, Maryland, United States, 20815 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
St. Luke's Sleep Medicine and Research Center | |
Chesterfield, Missouri, United States, 63017 | |
Clayton Sleep Institute | |
Maplewood, Missouri, United States, 63143 | |
United States, North Carolina | |
Med One Sleep | |
Fayetteville, North Carolina, United States, 28304 | |
United States, Pennsylvania | |
Pearl Clinical Research | |
Paoli, Pennsylvania, United States, 19301 | |
United States, South Carolina | |
SleepMed of South Carolina | |
Columbia, South Carolina, United States, 29201 |
Principal Investigator: | Richard B Berry, MD | UF Health Sleep Center |
Responsible Party: | NightBalance |
ClinicalTrials.gov Identifier: | NCT03061071 |
Other Study ID Numbers: |
US-2017-001 |
First Posted: | February 23, 2017 Key Record Dates |
Last Update Posted: | August 21, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Positional Sleep Apnea Positional Obstructive Sleep Apnea POSA |
OSA Obstructive Sleep Apnea Sleep Apnea |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |