Need Assistance? Call us today! 714-296-5151
By Jerry Hu, DDS, DASBA, DABDSM, DACSDD
Intro
Current consensus in the medical community on duration of quality sleep needed for a typical adult needs to be at a minimum of at least 7 hours at 7 nights per week. (ref 1.) With CPAP usage, the bar set for “compliance” comes notably short of the consensus recommendation. It is generally accepted compliance for CPAP at greater than 4 hours with at least 70% of the nights. (ref. 2). Moreover, after 6 months of usage, the adherence of CPAP users goes down to 50% and even further to 17% after 5 years. When CPAP is not being used, then those times can be potentially life threatening, as zero or no treatment is being utilized. In hypertensive OSA patients, studies show that minimum of 5.6 hours of CPAP usage is needed to sustain a long-term reduction in blood pressure. Therefore, it is important for clinicians to weigh in the mean disease alleviation (MDA), apnea burden/load and consideration of the Sarah Index (ref. 3) when determining what treatment option is best for suited the OSA patient. Furthermore, recent crossover studies show that with retrospective analysis, most patients preferred oral appliance therapy over CPAP for higher adherence and effectiveness in treatment outcomes. (ref. 4). A 2018 study done by Hu J. et al (ref. 5), has shown with oral appliance therapy with the Braebon compliance chip tracker, the mean usage for oral appliances was at 7.4 +/- 1.4 hours per night at 87.9% compliance, which shows far better success in outcomes regarding overall effectiveness of oral appliance therapy over CPAP treatment.
Discussion
In June of 2021, PHILIPS recalled a considerable number of their CPAP due to carcinogens and in April of 2024, the FDA consent in Decree against Philps Respironics following the recall of their machines (ref. 6). On January 29, 2024, FDA made a Class I recall, the most serious type of recall, against ResMed, Ltd. for their machines that cause magnetic interference with certain medical devices. Citing the seriousness of the issue, the FDA noted that certain implants and medical devices can malfunction causing serious harm, including death (ref. 7).
Also, 2024 research at Columbia University by Peker. Y, et al (ref. 8) shows CPAP increasing angiopoietin 2 pro-inflammatory response. The study shows the greater the CPAP pressure level, the greater the release of proinflammatory, lung distension- responsive angiopoietin-2 while reducing cardioprotective angiogenic factor VEGF, which would counteract the expected cardiovascular benefits using CPAP for OSA treatment. This means that patients should be informed before given CPAP treatment, if and when they use pressures above 7 on machine, they are increasing the risk of a cardiovascular event, due to the pressure causing increase in angiopoietin-2, and that would counteract any prior conclusions that claim CPAP lowers cardiovascular risk. Patients also need to understand the importance of properly cleaning and maintaining their CPAP machines. There has been cases of patients getting Legionnaires disease and infections from their CPAP when not cleaned appropriately (ref. 9). The biogunk in the water from CPAP and sputum when not cleaned appropriately shows Legionella pneumophila serotype 1 ST37, and that is a serious infection. Therefore, sleep centers need to forewarn the consequences of CPAP cleaning maintenance before they dispense a potentially hazardous treatment option.
Aerophagia and GERD with CPAP usage have also been published in the literature. A 2008 study showed that there is a relationship between GERD related LES patho-physiology and development of aerophagia in OSA patients using CPAP (ref. 10). Again, the risks and potentially negative consequences need to be told to all patients considering CPAP treatment prior to use. It is the duty of healthcare professionals to do no harm and stand by their oath.
CPAP treatment-emergent central sleep apnea also need to be disclosed to the patient before CPAP is dispensed. It is estimated that around 10% of all CPAP initial titrations result in the increase of central sleep apnea (ref. 11). There are also Mayo clinic studies that show with mask leakage, the chances of increasing CSA become notable during use of CPAP.
There are also some general considerations with CPAP machines the healthcare provider should consider before dispensing. The portability of the machine, as it would be difficult to take them to camping, hiking, and on certain work related activities. For shift workers, such as airline pilots and commercial truck drivers, the ease and use of oral appliances versus CPAP machines is considerably more practical. Regarding bed partners, the noises, etc. that comes from CPAP machines might worsen sleep quality and even cause more fragmented sleep in both the patient and bed partner.
In terms of overall effectiveness, one can see that due to compliance/ adherence to oral appliance therapy, the MDA of patients using OAT over CPAP is shown in the literature. This does not mean that OAT is bullet proof. The Sutherland study in 2019 (ref. 3) does show that for mild to moderate OSA, the non-responders to OAT can be up as high as 50 %. Non-responding means the AHI/RDI/REI reduction was not significant, but it is possible the pool of patients used in those studies did not have all the bite positions measured in three dimensions (3D). It would not be reasonable and fair to make conclusions and judgements on oral appliance therapy responders based only on one bite method with titrations or calibrations done only in one dimension, such as anterior-posterior (AP). If no lateral, vertical, pitch, roll, and yaw are considered, then it is unfair to label the patient as a non-responder if those different bite positions were never considered. If patients have deviated septum, prior car accidents, asymmetries, cranial distortions, side bends, etc. only evaluating one dimension and titrating only in one dimension does not give the proper thorough analysis the patient deserves before being labeled a “non responder” to oral appliance therapy.
Also, certain appliances harvest or retain more biogunk than others. Therefore, like CPAP potential risks for infection, the materials of the oral appliance used all matter. Materials such as nylon with more porosity, will trap bacteria and plaque, and that is noteworthy as well when discussing oral appliance selection and types for treatment.
When patients are true non-responders to OAT for OSA and they’re also CPAP intolerant or failed CPAP, then, other non-invasive to completely invasive treatment options are available. Myofunctional therapy in combination with any treatment with OSA have been shown in the literature to aid in reduction of AHI/RDI/REI (ref. 12). With tongue release (ankyloglossia), myofunctional therapy can go hand in hand with any treatment including oral appliance therapy. The following are also available options (and in no particular order of non-invasive to invasive)—craniofacial epigenetic/ pneumopedics, osseo-growth guidance, MSE II- Won Moon, MARPE/DOME (ref. 14 and 15) , SARPE, INSPIRE, Phrenic Nerve for CSA- ZOLL Itamar, MMA, and tracheostomy. Other options such as UPPP, etc. can be considered but it is important to look at success rates, relapse rates, and potential side effects from dehiscence, to bone loss, to root resorption.
Studies have also shown playing the didgeridoo or double winded instruments such as an English Horn or Oboe, can benefit reduction of AHI/RDI/REI (ref. 13). Randomized controlled studies were done showing the effectiveness with sleep apnea treatment with playing these musical instruments. Combining these treatment adjuncts can be beneficial to the overall outcome for the OSA patient, as well as proper nutrition, exercise and breathing (Buteyko breathing, ref. 16).
Conclusion
When considering compliance, comfort, portability, practicality, and patients’ preferences, the customized oral appliance therapy exceeds the effectiveness and MDA versus CPAP for treatment of OSA. Healthcare professionals have an oath and duty to do no harm, but also need to obtain full informed consent from patients after reviewing pros, cons, risks, benefits and all alternatives. When certain treatment modalities fail, it is also the duty of the clinician to offer other treatment methods, adjunctive choices, and to follow through with long term analysis.
References:
1. Watson NF, et al, Joint consensus statement AASM and Sleep Research Society, SLEEP 2015;38(6):843-844.
2. Sutherland K. et al, Efficacy vs effectiveness in the treatment of OSA: CPAP and oral appliances, JDSM 2015; 2 (4).
3. Sutherland K. et al., Oral Appliance Therapy for OSA: State of the Art; 2019: Dec. 2, doi: 10.3390/jcm8122121.
4. Almeida F., et. al, Long Term Effectiveness of Oral Appliance versus CPAP Therapy and the Emerging Importance of Understanding Patient Preferences, 2013, SLEEP, Sept 1; 36 (9): 1271-1272.
5. Hu, J, et. al, Evaluation of a New Oral Appliance with Objective Compliance Recording Capibility: a Feasibility Study; 2018; JDSM, article 3; issue 5.2
6. FDA News Release April 9, 2024, Federal court.
7. FDA ResMed LTd. Recalls; FDA.gov Jan. 2024.
8. Yuksel P, et. al, March 2024, EBioMedicine CPAP may promote endothelial inflammatory milieu in sleep apnoea after coranray revascularization.
9. Stolk J. et al. 2016 Legionella pneumonia after use of CPAP equipment
10. Watson N. et al, 2008 J Clin Sleep Med, Oct 15; 4 (5): 434-438.
11. Bradley, E et al. 2013 Aug 1; SLEEP, 36(8): 1121-1122.
12. Camacho M. et al, 2015 May 1; SLEEP, 38(5): 669-675. PMCID
13. Puhan M et al, .2006,BMJ Feb 4; 332 (7536): 266-270.
14. Kapetanovic A et al, 2022 June, Clin Oral Investig; 26 (10): 6253-6263.
15. Dominguez-M R et al; March 2024 Journal of Orofacial Orthopedics DOI: 10.1007/s00056-024-00521-6.
16. A. J. Opat et al. J. Asthma, 2000.