The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
NCT ID: NCT03061071
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2017-03-01
2018-07-12
Brief Summary
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Detailed Description
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The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
NightBalance Sleep Position Trainer (SPT)
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
Automated Adjusting Positive Airway Pressure (APAP)
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
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.
NightBalance Sleep Position Trainer (SPT)
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
Automated Adjusting Positive Airway Pressure (APAP)
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
Interventions
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NightBalance Sleep Position Trainer (SPT)
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
Automated Adjusting Positive Airway Pressure (APAP)
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
Eligibility Criteria
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Inclusion Criteria
2. 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%
3. Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Exclusion Criteria
2. A female of child-bearing potential that is pregnant or intends to become pregnant.
3. 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).
4. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
5. Oxygen use.
6. The presence of any other sleep disorder (central sleep apnea (CSA \>5), periodic limb movement disorder (PLMAI \>15), clinical diagnosis of insomnia or narcolepsy).
7. Excessive alcohol consumption (\>21 drinks/week).
8. The use of any illegal drug(s).
9. Night or rotating shift work.
10. Severe claustrophobia.
11. Shoulder, neck, or back complaints that restrict sleeping position.
12. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
20 Years
80 Years
ALL
No
Sponsors
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NightBalance
INDUSTRY
Responsible Party
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Principal Investigators
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Richard B Berry, MD
Role: PRINCIPAL_INVESTIGATOR
UF Health Sleep Center
Locations
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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
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
SleepMed of South Carolina
Columbia, South Carolina, United States
Countries
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References
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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.
Other Identifiers
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US-2017-001
Identifier Type: -
Identifier Source: org_study_id
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