Your question is understandable, but I'm not sure what direct comparison can be made because there is no compliance data for IHL42x, unless you count the dropout rate for our small cohort phase 2 proof of concept trial.
You'd have to go back to the releases relevant to those trial results to see how many people dropped out: my recollection was zero people dropped out. I seem to remember there was one person who had a significant adverse event during the trial that was unrelated to the medication itself, and perhaps that person had to withdraw or be withdrawn from the study? IHL42x was deemed to be very well tolerated, but as we know the study size was too small to draw any definitive conclusions. I think we are entitled to feel very confident it will have a high compliance rate based on results to date, but we do need our pivotal trial results, ultimately.
The following study found that overall compliance for CPAP is deemed to be 72.6%, but varies a lot depending on age and sex.
Age and sex disparities in adherence to CPAPIMPORTANT: in the context of that study, "compliance" means meeting the US Centers for Medicare and Medicaid services adherence threshold of ≥4 hours of use on 70% of nights in a consecutive 30-day period within the first 90 days. This threshold determines whether the cost of CPAP will be covered for the patient or not: no point wasting tax payer funds if the patient isn't going to use the device. Note that those who meet the threshold don't continue to use the device longer term to the same extent, and the threshold used during those first 90 days is not very high. The study found that across all demographics, CPAP use peaked early on (generally between the 2nd night and over a week after treatment initiation), but then declined. We can safely assume that longer term than the 90 days, compliance declines further especially considering that Medicare, Medicaid and most private insurers don't cover the cost if compliance threshold is not met during the first 90 days... how many people lose motivation and fall off the bandwagon shortly after they've secured insurance coverage for the device? Certainly, outside of the artificial environment of research studies, the reality is many people abandon CPAP use entirely.
Overall, it seems commonly accepted that long term, compliance is under 50%.
But what matters most when comparing the two treatment options is that even those who comply with CPAP long term would probably prefer to take a pill instead of sleeping with an external device strapped to their faces.
If you want to compare effectiveness, CPAP is considered virtually 100% effective BUT only while the OSA sufferer wears the device of course. Research participants seem to wear the device only 4.5 hours per night on average, and that figure is almost certainly much lower in the general population, without the added motivation and scrutiny of a study framework to boost compliance.
As for results for IHL42x so far:
"Average apnea hypopnea index (AHI) was reduced from 42.8 to 21.1 events/hour in the IHL-42X arm, a 50.7% reduction in AHI. Furthermore, 60% of participants experienced a greater than 55% reduction in AHI and 25% of treated participants displayed an 80% or greater reduction."
https://www.incannex.com/clinical-trail/ihl-42x-osa/But of course it is more complicated than this because IHL42x provided relief throughout the night, whereas CPAP only provides relief while the mask is being worn and most patients remove it at some point during the night due to discomfort. And there will be overall sleep quality advantages to a pill that avoids the discomfort of the CPAP machine mask.
A general philosophical question can be asked as to whether significant but partial improvement delivered 100% of the time is to be preferred over near 100% improvement delivered less than 70% of the time. I highly doubt we have the data to say for this application which approach will provide the best health outcomes and mortality reduction over the long term, but we probably all share the sense that slow and steady wins long term races.
Regardless: for most patients, the choice will be whether the almost irresistible convenience advantage of a pill over sleeping with a mask hugging their faces... can be trumped by the possibility that the mask
may have a slight edge in overall long term effectiveness.
Most of us aren't willing to sacrifice comfort in pursuit of the perfect night's sleep: there is a fundamental contradiction in the very notion. We're all putting our money on folks preferring up to 80% improvement IHL-42x seems to be delivering, over wearing a mask to bed.
In the end, the gold standard will be the method people actually choose to use.
Good luck mate!
