Personalized risk estimates have little bearing on reality. The best example of this is the level of safety we feel driving versus flying—though cars are many times more dangerous than airplanes. What it comes down to is the perception of control: we get to operate our own SUVs, but we leave flying up to the ‘friendly skies’.The same is true of the COVID-19 outbreak. While many of us seem willing to go to the supermarket or eat out amid the pandemic, the thought of returning to a healthcare setting is as appealing as a lunch with banana soup. Some are even avoiding the ER with symptoms of appendicitis or heart attack! But if you look closely, you can find many more layers of protection baked in to your average visit to the doctor than any Acme, and the reason for the avoidance may lie in the lack of control that we feel as patients.
Knowledge can bestow a sense of control. As patients, we don’t typically think to ask for a window to the inner workings of healthcare—sometimes we’re lucky just to get an itemized bill! In normal times, we trust the professionals to keep us safe. But in times like this, with the risk of virus exposure, that perception of control is needed—and a well-informed patient is a better patient.
I have an Sleep Study appointment. But we’re in a pandemic. What do I do now? You might think that Sleep is non-essential and can be put off until after the pandemic. And you’re not alone. More than 2/3 of sleep centers have seen a reduction in patients recently. But what if the pandemic becomes the “new-normal”? Quality sleep boosts the immune system, reducing the risk of infection, and can improve outcomes for people fighting a virus; on the other hand, poor sleep can weaken this line of defense and make someone susceptible to acquiring a virus. Treating a breathing disorder like Obstructive Sleep Apnea (OSA) can also reduce daytime sleepiness that leads to poor outcomes including accident risks. Untreated OSA leads to a cascade of negative health effects that are well documented, including poor cardiovascular outcomes and metabolic syndrome.
The “new normal” in the sleep center is a robust series of risk mitigation layers. It’s all about the layers; just like a good mask, the more layers of effective filtering, the more virus protection. What follows in this article is a review of how sleep centers are modifying operations to specifically manage the risks. Think of it as a comprehensive guide for the apprehensive patient on the “new normal” for infection & risk control in the sleep lab.
As you review this guide, it is important to keep in mind that the CDC sees each community as unique, and appropriate mitigation strategies will vary based on the level of community transmission. Additional mitigation strategies may be recommended or required by the federal, state or local government, local and state public health departments, health systems, or individual institutions. With this in mind, here is a list of some specific areas of layered protection in proper context.
Most sleep centers are layering this extensive list of baseline infection prevention practices:
1. Health care provider self-quarantine if ill or in the event of a known exposure
2. Staggered arrival times to prevent patient-to-patient exposure (e.g., 8:00pm and 9:00pm for evening studies; call from the parking lot upon arrival)
3. PPE doffed and donned by sleep technologists and clinic staff during patient interactions
4. Patient and caregiver / visitor masking when appropriate
5. Patient and staff screening and temperature checks
6. Enhanced cleaning procedures
7. Patient COVID-19 testing and quarantine before in-lab sleep studies
8. Triage to alternative care delivery when appropriate
9. Use of telehealth strategies when appropriate
Everything you wanted to know about your sleep study during a pandemic (but were afraid to ask!). For an exploration of some specific approaches to risk mitigation we look to two sleep center settings:
- Clinic layers of protection
During the pandemic, the percentage of clinic visits that took place virtually was in the single digits. As a result of the COVID, it’s now over 50%. Telehealth, a broad term referring to any remote healthcare service, is already common practice in Sleep medicine. If you have a machine to treat constant positive airway pressure (CPAP), you are already using a form of it called Telemonitoring, where usage data from your device is recorded and sent electronically to your provider to show therapy compliance. Telemedicine, the practice that allows sleep professionals to provide clinical care from a distance, has historically been a less often used format but it has many advantages, especially in today’s COVID-19 environment: it eliminates the outpatient clinic commute, waiting room exposures and delays in scheduling (which, with outpatient closures is currently more difficult than in the past). Most Telemedicine formats involve a web-based video visit platform that is easy to use. All you need is a webcam attached to your computer or laptop and an internet connection. Another option is by “smartphone.” During the pandemic, audio-only is permitted as well. A telemedicine encounter from a Sleep specialist is exactly the same as in in-person visit, except it is done remotely. Rules around these services continue to evolve, so you must check with your insurance provider before seeking any telehealth service for “up-to-the-minute” benefits. Regardless, during this epidemic there are more options for not only for the diagnosis but also the treatment of Sleep Apnea.
Before you get the go-ahead for sleep testing, you need to come to agreement with a QHCP (e.g., qualified health care professionals are typically MDs, DOs, or NPs) on a course of treatment. Typically this involves screening for sleep-related breathing disorder like OSA and treatment of a positive case with CPAP. Nowadays, the process resembles a more measured cost/benefit analysis of determining the priority of treatment based on the severity of your condition or likelihood of symptom improvement with and without treatment, called “triaging.” Triaging sets the stage for a more varied set of “precision” OSA treatment options that include but go beyond the gold standard therapy with CPAP. Alternative therapies to CPAP include oral appliance therapy (OAT); weight loss treatment; jaw repositioning surgery or surgery on the upper airway to remove tissue or to implant a nerve stimulator or other device to open up the airway; positional therapy for sleep apnea that predominantly occurs on the back position; or more than one approach called “combination therapy.”
One thing to consider regarding qualification for CPAP is that during this public health emergency, under certain conditions Medicare may cover PAP devices based on your doctor’s assessment without requiring in-lab or home sleep apnea test (HSAT). This is not expected to continue post-pandemic, but it is an important part of the triaging decision.
The process of “triaging” patients to treatment is a key step in modulating risk. Whether PAP is necessary, based on assessment of acute/short-term health or safety risks of temporary withdrawal of therapy, is a decision between you and your healthcare provider.
- Polysomnography (PSG) sleep study layers of protection
Your physician referral to PSG is not just a “nice-to-have” study—being scripted for a study it is an indication that you are at high risk for a sleep disorder that carries with it a cascade of health impacts that can have a significant impact on your quality of life. Diagnosing OSA can be done through full Polysomnography in the lab or by having a portable home sleep apnea test (HSAT) device mailed to you for use at home. In-lab PSG is the gold standard because it is attended by a trained sleep technologist, and the study data has added value due to the expanded physiology that is collected. With that said, HSAT is typically adequate for a subset of adult patients without complicating conditions (e.g., moderate to severe pulmonary disease, neuromuscular disease, congestive heart failure, and patients suspected of having other sleep disorders, including central sleep apnea, periodic limb movement disorder (PLMD), insomnia, parasomnias, circadian rhythm disorders, or narcolepsy).
• Patient screening
If a sleep study is to be performed in the lab, detailed screening procedures are performed before the arrival of every patient via phone calls, patient portals, or online self-assessment tools to identify people with respiratory illness and make every effort to ensure patients in the sleep lab are COVID negative. Upon arrival, patients are required to wear a mask or face covering before and after testing.
• COVID-19 pre-testing
The decision to require patient testing is based on availability, turnaround time, local/state regulations, and local transmission/prevalence rates. Possibility of false positives and negatives is another consideration. You are more likely to need a test before a therapeutic CPAP titration study than a diagnostic PSG where no CPAP is used in the lab. However, many labs require it for both tests. If you test positive, you may need to wait 14 days to retest before being accepted back for your sleep study.
• Patient & Personnel workflows
The typical ratio of patient to staff is 2:1 but there are cases during the pandemic where 1:1 is more typical, including nights with low census, studies where patients are not COVID-19 tested, communities where COVID-19 is increasing, or in patients with high-risk medical conditions. Patient flow changes include staggered arrival times (e.g., instead of all patients arriving at 9:00pm, scheduling one patient every 15 minutes between 8:00pm and 9:00pm). On the other hand, there is an increased effort on the part of sleep technologists and RTs to protect rest breaks and recovery time between shifts; if found to have been exposed to a potentially COVID-19 positive patient, they are being supported to follow employee health guidance at their institution regarding testing, quarantine and safe return to work. Personnel who develop respiratory symptoms (e.g., fever, cough, shortness of breath) are being instructed not to report to work. Sick leave policies have become much more flexible and consistent with public health guidance during this pandemic.
• Personal Protective Equipment (PPE)
Appropriate donning and doffing techniques for PPE are followed by staff conducting attended sleep studies. This includes surgical or NIOSH-approved N95 mask and can include face-mask and gown. In the event that an in-lab therapeutic CPAP study is performed, there is typically full and separate PPE dedicated for each patient (hung on a hook right outside the patient room). Patients are also typically required to mask or wear face coverings before and after study.
• Facility considerations
Common spaces are being altered to create spaced areas and even outdoor areas for meetings between patients and clinicians. Patients are being given private bathrooms and patient rooms are even being spaced with empty room in between. Sanitizer, masks, signage, and enhanced disinfection of facilities is typically being performed after every patient encounter. When possible, some facility areas are using portable room HEPA-filtrating or are being transitioned to “AIIR,” which the CDC defines as: “negative pressure in the room (so that air flows under the door gap into the room); and a specified minimum air flow rate; and direct exhaust of air from the room to the outside of the building or re-circulation of air through a HEPA filter before returning to circulation.”
• Equipment and infection control
Sleep labs are following CDC recommendations regarding cleaning of equipment. Some labs are going beyond this to provide ultraviolet light for disinfection. There are now hospital grade UV-C portable robots being employed at health systems and are used at many sleep labs. Sleep labs are replacing viral filters after each patient use and either disposing, disinfecting, or not using humidified air during titrations. Disposable equipment that used to be reusable, like electrodes, effort belts, thermistors, and oximetry probes. Even CPAP masks are routinely being discarded or given to patients during the pandemic. Tools of the trade like tape measures and marking pens that were reused in the past are being discarded after patient use. CPAP machine filters are being replaced after each patient, and humidifier chambers are either being disinfected, discarded between patients, or not used at all.
• Alternative care delivery treatment strategies
There is a movement underway to remove barriers to non-traditional healthcare resources. On March 6, Congress passed the Coronavirus Preparedness and Response Supplemental Appropriations Act. The legislation allows physicians and other health care professionals to bill Medicare fee-for-service for patient care delivered by telehealth during the current coronavirus public health emergency. Private insurance payers are also easing access to telehealth. Many of the treatment and diagnostic approaches are shifting to remote patient monitoring (RPM). Some sleep centers are increasing the use of HSAT units through mail delivery or using curbside pickup and return to reduce patient contact (instructional brochures, video or telemedicine consultations ensure proper set-up, as well as safe handling of the package upon arrival). Using single-use, fully disposable devices and/or components is an option to reduce the risk of virus transmission from surface contact. If using reusable HSAT devices, all units are being cleaned and disinfected according to manufacturer’s instructions and facility policies. As an extra precaution during this public health emergency, some sleep centers are removing a reusable device from service for at least 72 hours in addition to disinfection before its next use.
• PAP interface layers of protection.
According to the CDC, some procedures performed on patients are more likely to generate higher concentrations of infectious respiratory aerosols than coughing, sneezing, talking, or breathing. These aerosol generating procedures (AGPs) potentially put healthcare personnel and others at an increased risk for pathogen exposure and infection. One of the commonly performed medical procedures that the CDC cites as able to create uncontrolled respiratory secretions includes CPAP and Bilevel.
The risks of CPAP use during the public health crisis come down to two populations:
1.Risks to healthcare personnel and visitors from PAP therapy in the clinical space.
2.Risks to bed partners and family members during in-home PAP therapy.
The sleep centers are using the infection control procedures mapped out in this guide. Every source of contamination has been addressed, but when a patient removes their PPE and begins a CPAP titration, there is still no universally accepted way for labs to reduce the risk of AGPs transmission to the atmosphere in the patient room in the clinical space, or to reduce contamination in the home.
But what if there were a way to don PPE while being treated for CPAP therapy?
SleepWeaver® Prevent is designed to provide an additional level of isolation for PAP/NIV patients with known or suspected respiratory infections. This new “combination” mask uses an modified KN95 Mask to filter exhaled air from Circadiance's SleepWeaver 3D PAP Mask.
PAP Interface Selection & Fitting. The most glaring challenge for CPAP compliance in the new normal of remote treatment is in the selection and fitting of the CPAP interface. Even before COVID, up to 50% of new patients reported adverse events from their masks. It is no wonder that long-term compliance with CPAP therapy is poor.
During the public health emergency, an in-person trialing of masks are being conducted without CPAP pressure (in the lab, the titration can be set remotely after the technical staff leave the room). If a patient does not find one comfortable, another can be tried. With remote fitting becoming commonplace through virtual sessions conducted between lab, clinic or durable medical equipment (DME) companies and the patient, there arises an imperative to get it right the first time. This is why we are seeing a proliferation of mask selector apps and algorithms into the marketplace. But patients have better outcomes when they are able to work with a sleep professional using behavioral sleep medicine techniques as part of a mask desensitization protocol, to get adjusted to the mask and the pressure. Without that opportunity, patients will still need to try a series of masks until they find the “right one.” This is why we see Circadiance’s line of Skin-Friendly™ SleepWeaver® masks, becoming an even better option for patients who are not able to select and get their masks “fitted” in-person. Because SleepWeaver® masks are made of a flexible, lightweight, moisture-permeable cloth like the material in ski-clothing, they are by design able to produce the most skin-friendly profile and fit the greatest variety of facial shapes. With or without the use of a mask selection application, SleepWeaver® is made to avoid the greatest variety of adverse outcomes that contribute to mask discomfort and poor compliance.
Each of these safety practices, while indicative of the relative level of safety your sleep center is taking, are not necessarily met by every center. This is because of a number of influencing factors:
- The rate of your particular community transmission, from none through high or somewhere in between, will serve as a major influence to the level of safety measures that are needed to meet the likelihood of infected patients. This means that more safety measures will naturally be used in a region with high COVID-19 rates.
- The resources of your sleep institution, including the availability of PPE, staffing, equipment, and the existing infrastructure of the facility, will impact how well a sleep center will be able to adapt.
- The triaging process may limit higher-risk AGPs in the sleep center and rely more on telehealth workflows, reducing the need for stringent infection control.
Taken as a whole, I hope that you can use this guide to come up with a more accurate analysis of the real risks of moving forward in the care of your sleep disorder, and the wealth of additional options that you have to take the next step in treatment. A simple cost/benefit analysis should lead you to a more informed decision on whether this is the right time. Yes, regional and community variation will influence the number and restrictiveness of layers you will generally find at your sleep disorders center. But it’s safe to say it is a safe time, because your sleep disorders center is safer than it has ever been.
—Matthew Anastasi, BS RST RPSGT, Clinical Coordinator Consultant, Circadiance
- Centers for Disease Control and Prevention. Get the Facts About Coronavirus. https://www.cdc.gov/coronavirus/2019-ncov/index.html
- American Academy of Sleep Medicine. COVID-19 Resources. https://aasm.org/covid-19-resources/
- American Association of Sleep Technologists. COVID-19 Resources. https://www.aastweb.org/covid19response
- Centers for Disease Control and Prevention. Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html