I am starting a petition to make pressure-gated CPAP machines available over-the-counter

[JazzlikeChicken]

Hello Everyone!

I am posting here in hopes of garnering support for my petition to make CPAP and APAP machines over-the-counter in the United States. As a vast majority of you already receive treatment for your sleep apnea, you already understand the risks you face if you do not use your CPAP machines (Extreme Daytime Sleepiness, Hypertension, Stroke, Heart Attack, etc.). I am only here to reduce some of the high barriers to entry you may have faced prior to getting a prescription for your condition. Conservative estimates predict over 30 million Americans live with Obstructive Sleep Apnea, and over 85% of them are undiagnosed.

The goal of this petition is to not only reduce barriers to obtaining a APAP machine, but reducing the overall cost of the machine in a manner similar to when hearing-aids were made OTC in 2017. Prescription hearing-aids ranged in price from $7000-$8000, now OTC hearing aids can be bought at a fraction of the price at $800.

Australia is an example of a country that already has this system in place successfully, with APAP machines (4-20 cm H2O) available OTC. They practice "rent-to-own" models, where you can rent a machine and pay a monthly fee that goes toward the total cost amount of the machine itself.

There are genuine concerns regarding the contraindications of APAP to people who may have cardiac/respiratory failure, Central Sleep Apnea, gastric issues, and recent facial surgery; however, these risks can be mitigated by including infographics within packaging that express these dangers, as well as a maximum pressure limit of 10 cm H2O on OTC APAP machines. Literature shows 10 cm H2O is enough to treat the vast majority of OSA conditions mild and moderate, and the machine can be programmed to shut off if higher pressure is needed or Central Sleep Apnea is detected through Forced Oscillation Technique (FOT) seen in newer CPAP models.

Dr. David Behar submitted a similar petition in 2024 to the FDA and was subsequently rejected due to concerns placed by the American Academy of Sleep Medicine (AASM) regarding the necessity of Polysomnography to rule-out Central Sleep Apnea prior to application of CPAP. These are valid concerns; however, a study by Lehman in 2007 notes that central apneas begin to emerge or worsen at 12 cm H2O. Combined with the fact that Treatment-Emergent CSA is only prevalent in less than 1% of all CPAP-adherent patients, ensuring the rest of the undiagnosed population has access to A/CPAP as soon possible is more important (Liu 2017).

The 10 cm H2O gated system is intended for the undiagnosed uncomplicated patient population with mild to moderate OSA which make a vast majority of the sleep apnea bell curve at 82% (Ho 2011). For those will more severe OSA needing physician assistance, the shutdown of the machine will be a signifier to seek advanced help.

To end it off, this petition will go alongside an official FDA citizen petition as a supporting document to show public support. As the FDA has classified CPAP as a class II medical device needing prescription, they also have the power to make it OTC. Please sign the petition if you believe CPAP and APAP should be made over-the-counter!

https://c.org/qH8MCPQvGc
Above is the link to sign the petition. Thank you.

[Conrad]

I love this part, "There are genuine concerns regarding the contraindications of APAP to people who may have cardiac/respiratory failure, Central Sleep Apnea, gastric issues, and recent facial surgery; however, these risks can be mitigated by including infographics within packaging that express these dangers, as well as a maximum pressure limit of 10 cm H2O on OTC APAP machines."


You're making a HUGE assumption here. In my experience, people will NOT read the owner's manual or any documentation that comes with the machine. They'll assume that they can figure it out on their own and if they can't, there's always the internet. No need to read the manual when you have the internet.

[tlohse]

I don’t really think having cpap over the counter is a good idea. I think it’s always good to get a doctors approval and have a sleep study done and a way to show proof that you really need one. I don’t know if is possible but there is always the risk that someone could fake sleep apnea and abuse the system. So I am sorry who ever started this post I will not support this effort.

[D.H.]

10 cm H2O? That's not enough; my prescription is 17.

[JazzlikeChicken]

10 cm H2O? That's not enough; my prescription is 17.

This petition isn't intended for people with severe OSA, it's meant as an accessible means to obtaining treatment for people with mild to moderate OSA which make up 82% of the undiagnosed population. Extreme Daytime Sleepiness is found in a majority of patients who have 5-10 AHI, and increasing severity of hypertensive effects at 15 AHI.

[Janknitz]

10 cm H2O? That's not enough; my prescription is 17.

This petition isn't intended for people with severe OSA, it's meant as an accessible means to obtaining treatment for people with mild to moderate OSA which make up 82% of the undiagnosed population. Extreme Daytime Sleepiness is found in a majority of patients who have 5-10 AHI, and increasing severity of hypertensive effects at 15 AHI.

I'm in favor of OTC machines on the one hand, but also recognize it's a lot more complex that OTC hearing aids because people using OTC hearing aids can judge efficacy for themselves.

We often see people here who have been using CPAPs sometimes for years at a prescribed pressure that isn't effective in treating their OSA. How would people buying OTC judge that for themselves???

Please clarify: Are you talking about increased risk of hypertensive effects of CPAP at 15 cm/H20 or the fact that people with AHI over 15 have a higher risk of hypertension (no duh)???? If the former, please list the studies. How high is the risk?

[tlohse]

I guess you do have a good point there. I suppose this could be something useful if it would happen.

[Nocibur]

...my petition to make CPAP and APAP machines over-the-counter in the United States.

Yeah like that might ever happen.

But I guess everybody needs a hobby.

[tlohse]

Well even if it doesn’t do anything it’s the thought that counts.