OSA Study— Press Materials
OSA and its Effects
Obstructive Sleep Apnea (OSA) occurs when the tongue or parts of the throat relax during sleep and collapse to block the airway. When the airway is blocked, blood oxygen will fall, causing the person to wake up just enough to move the tongue forward. The severity of OSA is determined by the frequency of blockages during sleep.
Mild OSA 5-15 blockages per hour
Moderate OSA 15-30 blockages per hour
Severe OSA 30 or more blockages per hour
The patient will not remember waking up, but he will be denied the deep sleep his body needs. When airway blockages happen too frequently (more than five to ten times per hour), physicians often prescribe a Continuous Positive Airway Pressure machine, or CPAP, to restore breathing and restful sleep. With CPAP, pressurized air is pumped through a mask to keep a patient’s airway open throughout the night. While CPAP is usually effective in patients who can tolerate it, many patients cannot sleep while wearing a CPAP mask.
Current OSA Treatments
Besides the use of CPAP machines, surgery may be offered as an alternative to shrink or remove tissue causing the airway blockage.
Alternative OSA Treatment under Investigation
Since Summer 2008 the LENTE Clinic has been conducting an investigational clinical study to assess the safety and effectiveness of the Tangue Adnvancement ystem from Aspire Medical, inc.
To be eligible for this study, patients must meet the following criteria:
- Prior diagnosis of obstructive sleep apnea by polysomnography (sleep study)
- Normal to moderately overweight
- Inability to use CPAP
Vaclav Pavelec, MD, PhD, the study investigator, evaluates patients by these and other criteria.
After signing informed consent, clinical study patients undergo a surgical procedure, under general anesthesia, and receive a small implant placed at the base of the tongue and connected to the floor of the mouth.
The procedure is followed by an in-hospital and outpatient observation and investigation regarding safety, tolerability and effectiveness. The system is intended to keep the patient’s tongue in the front of the mouth during sleep to prevent the tongue from falling back and blocking the airway.
A sleep study is conducted between four and twelve weeks post-implantation. It is estimated that an individual patient’s post-implantation participation in the study is approximately six months.
Internet Links:
- European Academy of Sleep Medicine www.easm.de
- Česká společnost pro výzkum spánku a spánkovou medicínu www.sleep-society.cz
- European Respiratory Society http://dev.ersnet.org
- European Sleep Research Society http://www.esrs.eu
- German Sleep Society http://web.uni-marburg.de/sleep//dgsm
- Société Française de Recherche et Médecine du Sommeil www.sfrms.org
- American Sleep Apnea Association www.sleepapnea.org
- National Sleep Foundation www.sleepfoundation.org
About Apneon, Inc.
www.aspiremedical.com