ArticleNature and science of sleep2013
Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility.
Article in Nature and science of sleep, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Effectiveness of oral pressure therapy in obstructive sleep apnea: a systematic analysis.Sleep & breathing = Schlaf & Atmung · 2016Pooled it
- A novel intermittent negative air pressure device ameliorates obstructive sleep apnea syndrome in adults.Sleep & breathing = Schlaf & Atmung · 2019Article
- Article
- Improvements in current treatments and emerging therapies for adult obstructive sleep apnea.F1000prime reports · 2014Review
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis feasibility study examined the initial-use safety and effectiveness of a new noninvasive oral pressure therapy (OPT) system developed to treat obstructive sleep apnea (OSA).
methodsThe OPT system consists of a console that connects with flexible tubing to a premanufactured polymer mouthpiece. Through the mouthpiece, a pump in the console creates oral vacuum intended to move the soft palate anteriorly to decrease obstruction of the airway during sleep. The mouthpiece was produced in ten different sizes to accommodate a range of oral dimensions. Subjects with OSA in this single-center, single-night study underwent a polysomnography (PSG) study at baseline, followed by PSG during use of OPT.
resultsFifty-six men and 20 women, aged 50.8 ± 12.0 years (mean ± standard deviation [SD]), had OSA with apnea-hypopnea indices (AHI) greater than five events per hour at baseline. Body weight averaged 98.0 ± 18.2 kg (mean ± SD), body mass index ranged from 22.6 kg/m(2) to 57.9 kg/m(2) and averaged 32.5 ± 5.8 kg/m(2) (mean ± SD). OPT was generally well tolerated without any serious adverse events. Baseline AHI was 38.7 ± 27.5 events/hour (mean ± SD) and was reduced with treatment to 24.6 ± 25.7 events/hour (P < 0.001, Cohen's d 0.53). Treatment produced AHI less than or equal to ten events/hour in 38% of the subjects. Oxygen desaturation index was 30.1 ± 23.7 events/hour at baseline versus 15.8 ± 19.1 events/hour with treatment (P < 0.001, Cohen's d 0.66). The minimum oxygen saturation increased with treatment from 77.9 ± 8.3 to 82.2 ± 7.9 (P < 0.001, Cohen's d 0.53). Stage-N1 sleep shifts, total sleep-stage shifts, and awakenings were significantly reduced with treatment.
conclusionThis single-center, single-night feasibility study demonstrates that OPT can improve OSA in certain subjects identifiable by PSG during systematic usage. In appropriately responsive patients, OPT shows potential as a clinically useful new alternative for treatment of OSA without the need for custom manufacture of an oral device component.
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