- First ever randomized controlled study with 12-month follow-up comparing SPT to standard of care, Oral Appliance Therapy (OAT)
- SPT is demonstrated to be therapeutically equivalent to OAT in terms of treating positional sleep apnea and its symptoms
- SPT leads to fewer device related complaints and is more cost-effective
The Hague, the Netherlands – NightBalance, a leader in innovative obstructive sleep apnea (OSA) therapies, today announced the publication of a study comparing its innovative “Sleep Position Trainer” (SPT) to the historic standard of care oral appliance therapy (OAT) in mild to moderate positional obstructive sleep apnea (POSA) over a 12-month period. In this study SPT compared favorably to AOT. While the study demonstrated equally good clinical outcomes, SPT scored considerably better on ease of use, and showed fewer complications. This positions SPT as a potential future standard of care for mild to moderate POSA, offering patients better ease of use and patients and payors better economics.
The article, entitled “Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial,” is published in the peer-reviewed journal Sleep and Breathing (e-published online Sept. 15, 2017).
NightBalance’s Sleep Position Trainer provides a highly innovative and effective therapy for POSA. The current standard of care in the treatment of mild and moderate sleep apnea consists of OAT. OAT involves the use of invasive, denture-like appliances, which are associated with a considerable level of discomfort, and may lead to adverse events such as tooth pain, changes in tooth position, or temporomandibular dysfunction. By comparison, NightBalance’s SPT is worn in a strap around the chest, and gently and unnoticeably prompts patients not to sleep on their back (supine) to prevent positional obstructive sleep apnea. As such it is non-invasive, and leads to improved therapy adherence and patient comfort.
“This is the first ever long-term, randomized controlled trial comparing positional therapy using the SPT with OAT for the treatment of POSA,” said Professor Nico de Vries, MD, PhD, a leading expert in sleep disorders and Principal Investigator of the study. “Given these clinical outcomes, fewer device related complaints, and better economics, I believe the SPT is a strong contender to become a more comfortable, natural, and affordable solution for a large number of sleep apnea sufferers.”
“We are pleased with the positive results of the study,” said Eline Vrijland-van Beest, CEO of NightBalance. “These results add to our continuously expanding clinical data set of more than 80.000 nights in published research to date, demonstrating the ease of use and efficacy of the Sleep Position Trainer. Our focus on the generation of strong clinical data in collaboration with leading sleep disorder scientists and clinicians offers invaluable support for our interactions with patients, sleep specialists, regulatory bodies and payors.”
About the Sleep Position Trainer
NightBalance’s patent protected proprietary Sleep Position Trainer (SPT) prompts patients not to sleep on their back (supine), preventing positional obstructive sleep apnea. Worn in a strap around the chest, the SPT constantly measures the patients’ sleep position, and gently prompts users to change position without affecting their sleep. The SPT activates itself after 30 minutes, allowing patients to fall asleep in any desired position, and its smart hardware uses individually adjusted vibration strengths and patterns to assure sustained effectiveness. The SPT is prescribed by sleep specialists, ear, nose and throat specialists and pulmonologists.
NightBalance, founded in 2009 and based in The Hague, the Netherlands, developed and markets the Sleep Position Trainer, a proprietary, highly advanced and easy to use device to prevent positional obstructive sleep apnea. CE-marked since 2012, the SPT is currently sold in 11 European countries. NightBalance’s wealth of clinical data supports the efficacy and ease of use of the SPT, and has demonstrated a substantial increase in patient compliance versus traditional treatments for OSA.