Oral pressure therapy: Difference between revisions

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Oral pressure therapy (OPT) is a treatment for obstructive sleep apnea (OSA) that uses negative pressure in the mouth to shift the soft palate and tongue forward.^[1] The negative pressure is created by a bedside console connected by a small tube to a mouthpiece worn inside the mouth during sleep. The device is successful in between a quarter and a third of people.^[2]

Medical uses

While oral pressure therapy resulted in some benefit, most people were not fully treated by its use.^[2] The device was successful in between a quarter and a third of people.^[2]

Contraindications

Oral pressure therapy should not be used to treat central sleep apnea (CSA) or by anyone who has a severe respiratory disorder (e.g., severe lung disease, pneumothorax), has loose teeth or advanced periodontal disease, or is under the age of 18.

Regulation

One Oral Pressure Therapy medical device has been cleared by the FDA for sale with a prescription (the Winx Sleep Therapy System).^[3]

References

^ Schwab RJ, Kim C, Siegel L, Keenan BT, Black J, Farid-Moayer M, Podmore J, Vaska M (July 1, 2014). "Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea". Sleep. 37 (7): 1237–1247. doi:10.5665/sleep.3846. PMC 4098809.
^ ^a ^b ^c Nigam, G; Pathak, C; Riaz, M (May 2016). "Effectiveness of oral pressure therapy in obstructive sleep apnea: a systematic analysis". Sleep & breathing = Schlaf & Atmung. 20 (2): 663–71. PMID 26483265.
^ "510(K) Notification" (PDF). accessdata.fda.gov. October 31, 2012.

[1] Schwab RJ, Kim C, Siegel L, Keenan BT, Black J, Farid-Moayer M, Podmore J, Vaska M (July 1, 2014). "Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea". Sleep. 37 (7): 1237–1247. doi:10.5665/sleep.3846. PMC 4098809.

[Nig2016-2] Nigam, G; Pathak, C; Riaz, M (May 2016). "Effectiveness of oral pressure therapy in obstructive sleep apnea: a systematic analysis". Sleep & breathing = Schlaf & Atmung. 20 (2): 663–71. PMID 26483265.

[3] "510(K) Notification" (PDF). accessdata.fda.gov. October 31, 2012.

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 {{New unreviewed article|date=June 2016}}
-'''Oral pressure therapy''', otherwise known as '''OPT''', is a treatment for [[obstructive sleep apnea]] (OSA) that uses negative pressure in the mouth to shift the soft palate and tongue forward, improving airflow during sleep by relieving tissue obstruction in the airway.<ref>{{cite journal |vauthors= ((Schwab RJ)), ((Kim C)), ((Siegel L)), ((Keenan BT)), ((Black J)), ((Farid-Moayer M)), ((Podmore J)), ((Vaska M)) |date=July 1, 2014 |title=Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea |url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4098809/ |journal=Sleep |volume=37 |issue=7 |pages=1237–1247 |doi=10.5665/sleep.3846 |pmc=4098809 }}</ref>  The negative pressure is created by a bedside console connected by a small tube to a mouthpiece worn inside the mouth during sleep.  Unlike [[Continuous positive airway pressure|CPAP]], Oral Pressure Therapy does not apply pressure directly to the airway, but applies light negative pressure in the oral cavity.  With this system, the user breathes normally through the nose with the mouth closed.  Unlike [[mandibular advancement splint|mandibular repositioning devices]] (also known as oral appliances and dental devices), Oral Pressure Therapy does not pull the lower jaw forward.
+'''Oral pressure therapy''' ('''OPT''') is a treatment for [[obstructive sleep apnea]] (OSA) that uses negative pressure in the mouth to shift the soft palate and tongue forward.<ref>{{cite journal |vauthors= ((Schwab RJ)), ((Kim C)), ((Siegel L)), ((Keenan BT)), ((Black J)), ((Farid-Moayer M)), ((Podmore J)), ((Vaska M)) |date=July 1, 2014 |title=Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea |url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4098809/ |journal=Sleep |volume=37 |issue=7 |pages=1237–1247 |doi=10.5665/sleep.3846 |pmc=4098809 }}</ref>  The negative pressure is created by a bedside console connected by a small tube to a mouthpiece worn inside the mouth during sleep. The device is successful in between a quarter and a third of people.<ref name=Nig2016/>
-== Clinical studies ==
+== Medical uses ==
+While oral pressure therapy resulted in some benefit, most people were not fully treated by its use.<ref name=Nig2016>{{cite journal|last1=Nigam|first1=G|last2=Pathak|first2=C|last3=Riaz|first3=M|title=Effectiveness of oral pressure therapy in obstructive sleep apnea: a systematic analysis.|journal=Sleep & breathing = Schlaf & Atmung|date=May 2016|volume=20|issue=2|pages=663-71|pmid=26483265}}</ref> The device was successful in between a quarter and a third of people.<ref name=Nig2016/>
-The ATLAST clinical trial demonstrated that Oral Pressure Therapy is effective and safe for the treatment of obstructive sleep apnea.<ref>https://clinicaltrials.gov/show/NCT01146782</ref><ref>{{cite journal |vauthors= ((Colrain IM)), ((Black J)), ((Siegel LC)), ((Bogan RK)), ((Becker PM)), ((Farid-Moayer M)), ((Goldberg R)), ((Lankford DA)), ((Goldberg AN)), ((Malhotra A)) |date=September 2013 |title=A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea |url=http://www.sleep-journal.com/article/S1389-9457%2813%2900187-1/abstract |journal=Sleep Journal |volume=14 |issue=9 }}</ref>   Responders were easily identified, achieving a median [[Apnea–hypopnea index|AHI]] reduction from 26.2 to 5.7,<ref>{{cite web |url=http://apnicure.com/wp-content/uploads/2012/11/ESRS-2012-MultiCentre-Evaluation-of-OPT-for-OSA-Sleep-Architecture.pdf |title=A Multi-center Evaluation of Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea: sleep architecture effects }}</ref>  compliance (continued use during the trial) was high, with high patient and bed partner satisfaction.  76% of subjects report they would continue to use Oral Pressure Therapy to treat their OSA.<ref>{{cite journal |vauthors= ((Colrain IM)), ((Black J)), ((Siegel LC)), ((Bogan RK)), ((Becker PM)), ((Farid-Moayer M)), ((Goldberg R)), ((Lankford DA)), ((Goldberg AN)), ((Malhotra A)) |date=September 2013 |title=A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea |url=http://www.sleep-journal.com/article/S1389-9457%2813%2900187-1/abstract |journal=Sleep Journal |volume=14 |issue=9 }}</ref>   Like other treatments for sleep apnea, a subset of trial participants did not respond to the therapy.
 == Contraindications ==
+Oral pressure therapy should not be used to treat [[central sleep apnea]] (CSA) or by anyone who has a severe respiratory disorder (e.g., severe lung disease, pneumothorax), has loose teeth or advanced periodontal disease, or is under the age of 18.
-Oral Pressure Therapy should not be used to treat [[central sleep apnea]] (CSA) or by anyone who has a severe respiratory disorder (e.g., severe lung disease, pneumothorax), has loose teeth or advanced periodontal disease, or is under the age of 18.
 == Regulation ==