The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea

Completed · Not applicable

Conditions studied: Sleep Apnea Syndromes

In brief

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).

Key facts

Study ID

NCT03061071

Run by

NightBalance

People needed

117

Starts

2017-03-01

Expected to finish

2018-07-12

Last updated by the study team

2018-08-21

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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