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

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.

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):

• 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.