"please keep me updated about oximeters "
Sleep Apnea Forum Bringing Power to the Patient
New? Free Sign Up
Then check our Welcome Center to a Community Caring about Sleep Apnea diagnosis and Sleep Apnea treatment:
CPAP machines, Sleep Apnea surgery and dental appliances.
CPAP Supplies
Latest Activity
Oral Devices Are As Effective as CPAP
PubMed abstract:
Respiration. 2010 Oct 20. [Epub ahead of print]ral Appliance Therapy versus Nasal Continuous Positive Airway Pressure in Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial.
Aarab G, Lobbezoo F, Hamburger HL, Naeije M.
Department of Oral Kinesiology, Academic Center for Dentistry Amsterdam, Research Institute MOVE, University of Amsterdam and VU University Amsterdam, The Netherlands.
Abstract
Background: Previous randomized controlled trials have addressed the efficacy of mandibular advancement devices (MADs) in the treatment of obstructive sleep apnea (OSA). Their common control condition, nasal continuous positive airway pressure (nCPAP), was frequently found to be superior to MAD therapy. However, in most of these studies, only nCPAP was titrated objectively but not MAD. To enable an unbiased comparison between both treatment modalities, the MAD should be titrated objectively as well. Objective: The aim of the present study was to compare the treatment effects of a titrated MAD with those of nCPAP and an intra-oral placebo device. Methods: Sixty-four mild/moderate patients with obstructive sleep apnea (OSA; 52.0 +- 9.6 years) were randomly assigned to three parallel groups: MAD, nCPAP and placebo device. From all patients, two polysomnographic recordings were obtained at the hospital: one before treatment and one after approximately 6 months of treatment. Results: The change in the apnea-hypopnea index (AHI) between baseline and therapy evaluation differed significantly between the three therapy groups (ANCOVA; p = 0.000). No differences in the AHI were found between the MAD and nCPAP therapy (p = 0.092), whereas the changes in AHI in these groups were significantly larger than those in the placebo group (p = 0.000 and 0.002, respectively). Conclusion: There is no clinically relevant difference between MAD and nCPAP in the treatment of mild/moderate OSA when both treatment modalities are titrated objectively.
Copyright 2010 S. Karger AG, Basel.
PMID: 20962502 [PubMed - as supplied by publisher]
Respiration. 2010 Oct 20. [Epub ahead of print]ral Appliance Therapy versus Nasal Continuous Positive Airway Pressure in Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial.
Aarab G, Lobbezoo F, Hamburger HL, Naeije M.
Department of Oral Kinesiology, Academic Center for Dentistry Amsterdam, Research Institute MOVE, University of Amsterdam and VU University Amsterdam, The Netherlands.
Abstract
Background: Previous randomized controlled trials have addressed the efficacy of mandibular advancement devices (MADs) in the treatment of obstructive sleep apnea (OSA). Their common control condition, nasal continuous positive airway pressure (nCPAP), was frequently found to be superior to MAD therapy. However, in most of these studies, only nCPAP was titrated objectively but not MAD. To enable an unbiased comparison between both treatment modalities, the MAD should be titrated objectively as well. Objective: The aim of the present study was to compare the treatment effects of a titrated MAD with those of nCPAP and an intra-oral placebo device. Methods: Sixty-four mild/moderate patients with obstructive sleep apnea (OSA; 52.0 +- 9.6 years) were randomly assigned to three parallel groups: MAD, nCPAP and placebo device. From all patients, two polysomnographic recordings were obtained at the hospital: one before treatment and one after approximately 6 months of treatment. Results: The change in the apnea-hypopnea index (AHI) between baseline and therapy evaluation differed significantly between the three therapy groups (ANCOVA; p = 0.000). No differences in the AHI were found between the MAD and nCPAP therapy (p = 0.092), whereas the changes in AHI in these groups were significantly larger than those in the placebo group (p = 0.000 and 0.002, respectively). Conclusion: There is no clinically relevant difference between MAD and nCPAP in the treatment of mild/moderate OSA when both treatment modalities are titrated objectively.
Copyright 2010 S. Karger AG, Basel.
PMID: 20962502 [PubMed - as supplied by publisher]
Views: 109
Replies to This Discussion
-
Permalink Reply by Mike on
-
Love it! The more effective treatment options, the better. Plus, the folks behind CPAP are too fat and happy. They could use the competition to redirect their focus from their customers to the patient.
-
Permalink Reply by RockRpsgt on
-
In order to to be truly objective the study should have measured RDI rather than AHI. AHI does not include RERAS. In my opinion we have no idea if these people were really helped or not. They could have been left with UARS.
-
Permalink Reply by Jackie James on
-
It is important that we not confuse effectiveness with efficacy. In studies, CPAP has been shown to be more efficacious in the treatment of OSA however compliance is poor with some studies showing as much as 50% of CPAP users failing to meet even the minimum compliance requirements set by Medicare (and the bar for compliance is set very low). On the other hand, oral appliance therapy has shown a slightly less rate of efficacy but much greater rates of patient compliance. Effectiveness = Efficacy X Compliance making it quite possible that the effectiveness of oral appliance therapy is equal to or greater than CPAP.
Because of the poor compliance with CPAP, Medicare just issued a new Coverage Determination that patients diagnosed with Obstructive sleep Apnea may elect a MAD as a first line of therapy as opposed to having to fail CPAP first. This new coverage determination goes into effect Jan 3, 2011.
-
Permalink Reply by Banyon on
-
Thanks Jackie. That news about Medicare is very interesting.
Will they pay for a followup PSG to test efficacy of MAD?
Do you know how much they will pay for a MAD?
-
-
Banyon,
yes, Medicare will allow a follow up PSG on the same basis as they allow them for other treatment modalities. I do not know how much they will pay yet, the allowable should be released before year end.
Regards,
Jackie
-
-
So jnk, Will you go so far as to say in this case government policy is going to be doing a big disservice to Medicare patients?
-
-
Unfortunatly, most of the studies on oral appliances are obsolete unless the study has been done on the devices that can move the jaw to maximum protrusion. The studies on these appliances, particularly the TAP show efficacy comparable to cpap. (Hoekema, et al). If studies on cpap were done on machines that only had one pressure and it was 10 or has a variable pressure from 4 to 10 then the results would be very poor. So the newer studies must be used and the appliance must be capable of reaching maximum protrusion. Second, the newer studies are randomized, placebo controlled trials with very good data. There are a large number of these that show excellent results and are comparable to cpap. Third, there are no studies or very few studies that are "intent to treat" studies on cpap. With "intent to treat" all of the non-compliant patients would have to be added to the numerator. Weaver has shown in her review of 12 major centers that the failure rate for cpap is from 49% to 83%. This study was done in 2009. This is not wearing the cpap. A cpap doesn't record not wearing it. If we assume that over half the patients are not wearing a cpap after one year and the rest average only half the night then the results would be much worse. There is no study showing the number of events once the cpap is removed. If we assume that the last half of the night the patient is not wearing it and that osa usually gets worse the second half of the night due to increase in REM, then the numbers for the success of cpap in the titration would be cut in half based on adherance. In other words, a patient who had an ahi/rdi of 60 and 0 with cpap would have an ahi/rdi of 30 if he wore it half the time.
In all crossover studies, oral appliances are preferred over cpap.
Oral appliances can easily be titrated in a sleep lab. ( see studies by Parker, Sherr, Roberts, and several others).
Oral appliances can easily be titrated by home sleep studies at a much lower cost than going back to a sleep lab.
Oral appliances always stiffen the pharynx with mandibular protrusion, it always lowers closing pressures so all patients can benefit from oral appliances. This is no different than a jaw thrust manuever in cpr. There are some new studies showing improved success using cpap and oral appliances.
Remmers and Isono have shown that the pcrit is lowered in the velo, oral and hypo pharynx, although not quite as much as in the hypo pharynx.
Finally, the AASM in their extensive review of oral appliances have changed their practice parameters to say that a patient "should" be give a choice between a cpap and and oral appliance. jnk may have experienced the benefits of combination therapy and the ability to achieve optimal results with lower pressures.
-
Permalink Reply by 99 on
-
look at the source of the infomation and you will see it is bias
Department of Oral Kinesiology, Academic Center for Dentistry Amsterdam, Research Institute MOVE, University of Amsterdam and VU University Amsterdam, The Netherlands.
what we need an unbias report or abstract like cpap users giving it the thumbs up
i do not think that is going to happen
-
-
I am with you 99. I have seen many great studies done on both oral and PAP devices. Many of these I have had to throw aside due to biased party interest.
99 said:look at the source of the infomation and you will see it is bias
Department of Oral Kinesiology, Academic Center for Dentistry Amsterdam, Research Institute MOVE, University of Amsterdam and VU University Amsterdam, The Netherlands.
what we need an unbias report or abstract like cpap users giving it the thumbs up
i do not think that is going to happen
-
-
You can titrate an appliance effectively over time and then follow up with sleep studies. If the patient isn't wearing their CPAP does it matter if it takes two weeks to titrate out their appliance? Your ignorance frustrates me?
j n k said:First of all, true objective titration of MAD would require its implementation to be MUCH more expensive than PAP therapy. PAP machines with data can establish efficacy all night every night, and we all recognize how important that data is to patients and clinicians, don't we? MADs do not provide that data and therefore would require PSG data on a regular basis to establish and maintain proof of efficacy in an objective way. One PSG 6 months later is not enough.
Second, the vast majority of all patients with OSA who use PAP benefit from it, regardless of anatomy, since the entire airway is addressed by the treatment. MAD addresses one location of possible obstruction, and there is not yet a viable protocol for establishing WHICH patients are likely to benefit. That makes prescription of MAD a very expensive crap shoot indeed, especially with repeated titrations during the process of proving a patient, after the fact, has turned out not to be a good candidate for MAD, as far as lowering AHI to an acceptable level. What a shame that patients in the study had to wait 6 months to get a PSG to find out if their treatment was acceptably lowering AHI! That would be a lousy protocol for sure!!
Third, truly randomized large-scale long-term studies are needed before the "findings" of one little study of 64 patients amounts to a hill of beans. The vast majority of studies that have been done have found that MAD as a first option offered to patients makes little or no sense financially or medically or in any other way.
Trying to twist these study results into supposed "proof" that MAD is a good first choice for the majority of patients, when scores of studies have failed to support that notion, does a great disservice to the many people who need to be advised according to the science of the day: PAP therapy is the gold standard, when used, and has the greatest likelihood of doing the greatest good for the largest amount of patients. That is why MAD is for people who can't make PAP work for them. Period.
MAD, like surgery, is a very valuable second-best ALTERNATIVE to the best treatment so far found for keeping someone's airway open during sleep--PAP therapy. It is my opinion that (1) good, (2) honest doctors (like Dr. Park) make that clear to every patient they speak to (as he does).
And just as it would be unfair to compare the MADs from 15 years ago to today's PAP machines, it is just as unfair to compare the success of those using today's MAD devices to the compliance figures for PAP use from 15 years ago.
Off my soapbox. Sorry for the rant.
-jeff
-
-
I didn't call him igorant I stated his ignorance (about oral appliances which was implied) frustrated me. I guess I need to be more clear.
Mary Z said:bkp, we don't call each other ignorant on this forum. You are welcome to disagree, but don't be ugly about it.
Mary Z.
bkp said:You can titrate an appliance effectively over time and then follow up with sleep studies. If the patient isn't wearing their CPAP does it matter if it takes two weeks to titrate out their appliance? Your ignorance frustrates me
© 2024 Created by The SleepGuide Crew.
Powered by
