Abstract
Purposes
Continuous positive airway pressure (CPAP) is the current standard of care for the treatment of obstructive sleep apnea (OSA). It is known that there is a low rate of adherence in many patients. Oral appliance therapy (OAT) is effective in patients with mild-to-moderate OSA. The efficacy of OAT in severe patients is unknown. The aim of this study is to evaluate treatment using an in-laboratory titration method to determine whether OAT might be appropriate for patients with severe OSA.
Methods
This is an IRB approved, retrospective study of 41 adults (mean age 51 years; 73% male) with severe OSA who were intolerant of CPAP therapy. All patients were treated with OAT (OASYS Oral–Nasal Airway System™). The sample was sub-divided into severe [Apnea–Hypopnea Index (AHI > 30 < 50)] and very severe (AHI > 50) groups. Informed consent was obtained from all patients included in the study. The device was custom fit by a dentist. After patients reported subjective symptom improvement, titration polysomnography was performed. If obstructive events were still noted after 90 min of the sleep study, an attending sleep technologist titrated the device in vivo in 1 mm increments for a maximum of 3 mm to optimize effectiveness.
Results
For severe cases, almost half (46%) were resolved with a post-treatment AHI < 5, while two-thirds (66%) had an AHI < 10. For very severe cases, 43% were resolved with a post-treatment AHI < 5, while 64% had an AHI < 10. All findings were statistically significant (p < 0.001).
Conclusions
This preliminary study supports the notion that oral appliance therapy using the OASYS Oral–Nasal Airway System™ may be effective in severe cases of OSA.
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Abbreviations
- AHI:
-
Apnea–Hypopnea Index
- AASM:
-
American academy of sleep medicine
- BMI:
-
Body mass index
- CPAP:
-
Continuous positive airway pressure
- ENT:
-
Ear nose throat
- ECG:
-
Electrocardiogram
- EEG:
-
Electroencephalogram
- EMG:
-
Electromyography
- EOG:
-
Electrooculogram
- FDA:
-
Food and drug administration
- OSA:
-
Obstructive sleep apnea
- OAT:
-
Oral appliance therapy
- PSG:
-
Polysomnography
- REM:
-
Rapid eye movement
- RDI:
-
Respiratory distress index
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Acknowledgements
The authors are indebted to Richa Shrivastava, BS for statistical analysis; Dennis Bashaw, MLIS and G. Dave Singh, DMD PhD DDSc for manuscript preparation.
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This study did not receive any intra- or extramural financial support. There is no conflict of interest, off label or investigational use of any product or service discussed in this article.
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Drs. John and Michael Bixby performed all the clinical work. All post-treatment sleep studies were performed at Sleep Dynamics—Center for Diagnosis of Sleep Disorders—An AASM Accredited Center. 2240 State Highway 33, Suite 114, Neptune City, NJ 07753.
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Shrivastava, D., Bixby, J.K., Livornese, D.S. et al. Efficacy of Oral Appliance Therapy in the Treatment of Severe OSA in CPAP-Resistant Cases. Sleep Vigilance 2, 119–125 (2018). https://doi.org/10.1007/s41782-018-0044-y
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DOI: https://doi.org/10.1007/s41782-018-0044-y