key: cord-0787163-h3xww0wa
authors: Schiza, Sophia; Simonds, Anita; Randerath, Winfried; Fanfulla, Francesco; Testelmans, Dries; Grote, Ludger; Montserrat, Joseph M.; Pepin, Jean-Louis; Verbracken, Johan; Ersu, Refika; Bonsignore, Maria R
title: Sleep Laboratories Reopening and COVID-19: A European Perspective
date: 2020-11-19
journal: Eur Respir J
DOI: 10.1183/13993003.02722-2020
sha: 77e9b384713ddfd7336f9cfee49dce4c9a0582a4
doc_id: 787163
cord_uid: h3xww0wa

The clinical activities regarding sleep disordered breathing (SDB) have been sharply interrupted during the initial phase of the COVID-19 epidemic throughout Europe. In the last months, activities have gradually restarted, according to epidemiological phase of COVID-19 and National recommendations. The recent increase in cases throughout Europe obliges to reconsider management strategies of SDB accordingly. Diagnosis of SDB and initiation of treatment pose some specific problems to be addressed to preserve safety of the patients and health personnel. This perspective document by a group of European sleep experts aims at summarising some different approaches followed in Europe and United States, which reflect National recommendations according to the epidemiological phase of the COVID-19 infection. Respiratory sleep medicine will likely change in the near future, and use of telemedicine will grow to avoid unnecessary risks and continue to provide optimal care to the patients. The document also covers pediatric sleep studies and indications for titration of noninvasive ventilation, as well as precautions to be followed by patients who are already on positive airway pressure treatment. A single consensus document developed by the European Respiratory Society and National Societies would be desirable to harmonise SDB management throughout Europe.

The COVID-19 pandemic has caused interruption of non-urgent health services to reduce the risk of infection and limit spreading of the virus especially in hospital environments. In addition, the staff of Sleep laboratories was often re-allocated to other medical services under pressure, for example Respiratory Medicine. This has caused the almost complete closure of Sleep laboratories and clinics during lockdown in Europe (1) as in other parts of the world (2) (3) (4) . As a further precaution, children, pregnant women and patients at risk for severe forms of COVID-19 with pre-existing cardio-respiratory disease were excluded from evaluation of sleep-related problems.

Several National guidance documents have been produced in Europe on the gradual reopening of Sleep Services, and differences among them reflect National policies, reimbursement rules or the relative role of mostly public versus private practices.

The aim of this perspective document is to propose a shared flexible model to be adapted locally, based on safe practice and the guidance and experiences developed in different European countries. This is particularly relevant since, after the initial phase of the pandemic, a new surge in the number of cases is occurring in several European countries. We analysed similarities and differences of some National recommendations regarding evaluation and treatment of obstructive sleep apnoea (OSA) in adults.

Fewer recommendations were found on home noninvasive ventilation (NIV) and pediatric sleep disorders. Flowcharts approved by the European expert panel involved in this work provide the reader with a graphical, easy to consult summary for: access to the sleep lab (COVID-19 screening, Figure 1 ), diagnostic procedures (Diagnosis, Figure 2 ), and positive airway pressure (PAP) titration procedures (Treatment, Figure 3 ).

Boxes 1-3 and Supplementary eTables 1-3 summarise the approaches suggested for Screening for COVID-19, Diagnosis, and Treatment of sleep-disordered breathing (SDB), respectively, by the main documents available to date (2) (3) (4) (5) (6) (7) (8) . The document developed by the American Academy of Sleep Medicine (AASM) was among the first establishing the criteria for gradual reopening of sleep laboratories according to the local epidemiology of COVID-19 (2) . The approach followed by the Spanish Society of Pneumonology and Thoracic Surgery (SEPAR) was similar, but used the lockdown phases according to the indications by the Spanish Government reflecting the epidemiological situation (5) . In Italy, specific indications regarding sleep laboratories to be used all over the country have been published (6) , as in Canada (4), Germany (7) and UK (8) . More recently, a task force of the Association of Pulmonary, Critical Care, and Sleep Division Directors (APCCSDD) and the American Thoracic Society (ATS) (3), took into consideration both the clinical needs of the patients and the epidemiological phase of COVID-19 pandemic. Each Sleep Clinic or Laboratory will have to adapt its strategy to the current local prevalence of COVID-19 infection, with relatively loose precautions when the number of cases is low, and increasing levels of precautions when the number of cases and the risk of transmission are high.  a pre-triage phone-call the day before the planned appointment;

 Priority for tele/video-consultation and/or telemedicine Some National documents recommend avoidance of face-to-face visits according to the epidemiological situation, i.e. when contagion rate is increasing or high, and the clinical status of the patient allows successful management at home without risk. This strategy is more easily applicable to follow-up than to the first access visits. When there is high risk of COVID-19 transmission and the patient needs to be seen in person, COVID-19 testing before access to the Sleep Clinic is generally recommended.

All documents agree on the need to apply strict screening rules for COVID-19 in case of in person visits of the patient to the Sleep Centers (e- Table 1 ). These include:

 Patients are checked at the time of the appointment for temperature, COVID-19 symptoms and testing status upon their arrival at the sleep lab.

 only the patient is admitted to the visit room, unless an accompanying person is necessary;

 maintenance of safe distance and use of mask and gloves by the patients in some, but not all, countries;

 appropriate protective equipment worn by the health personnel;  sanitisation of surfaces and cleaning of the room after the visit;

 proper ventilation of the room between patients.

In the acute epidemic phase, in-laboratory sleep tests should be avoided, and home sleep tests should be preferred. Recommendations focus on the equipment to be sent to the patient's home, or taken by the patient, with detailed instructions on how to do montage. Disposable equipment should be preferred, and external sanitisation of the devices is mandatory.

It has been hypothesized that the virus may reach, via the nasal cannula, the nasal pressure transducer which cannot be sterilised. To avoid this risk, the AASM recommends no use of the polygraph for 72 h between tests on different patients (2) . This is a considerable limitation, especially if one considers the usual high demand of diagnostic sleep tests, possibly increased by the long interruption of sleep services. Low-cost ultraviolet C-machines have been proposed to sterilise non-disposable equipment (9) in alternative to standard hospital sanitization procedures.

Single-use, disposable equipment is commercially available for sleep recordings, but the cost is higher than for traditional recordings. Other strategies to improve safety are based on substitution of nasal cannula/thermistor with use of respiratory inductive plethysmography (RIP) (6) .

Although portable sleep studies seem to be preferred by the majority of European centers, in-laboratory polysomnography (PSG) is obtained in some countries, i.e. Germany, Belgium, France. Negative results of the COVID-19 PCR test are usually, but not always, required before PSG.

Additional measures to reduce personnel exposure and minimize risk are:

 decreasing the ratio patients/technicians in the Sleep lab during overnight studies;

 applying rotations of the personnel.

This is most challenging step because of droplet/aerosol dispersion generated during PAP therapy, and the associated risk to the health personnel (10) (11) (12) . For OSA patients, use of automatic CPAP devices with remote monitoring is preferred, thus avoiding the return of the patient to the Sleep Laboratory.

Ideally, the same PAP machine used for automatic titration should be prescribed to the patient, to avoid use of a single ventilator for titration in different patients. In some units a fixed pressure device is provided for titration, and adjustment of pressure is performed remotely by telemonitoring.

Droplet generation and dispersion, when vented masks are used, is not well documented but might represent a real, preventable risk. A circuit using non vented masks, two antibacterial/ antiviral filters and a safety valve has been proposed, especially in cases of relevant epidemiological risk (11) . The health personnel should use extended PPE during the titration (3) (4) (5) (6) (7) (8) . An alternative approach is to

show the patient how to use the ventilator as an outpatient, and then support initiation in the home with telemonitoring to facilitate titration. This is a modification of the home initiation protocol used by Duiverman et al (14) .

For home ventilator setting titration, routine TCO2 monitoring is recommended if non-vented masks are used during the initial assessment. Home transcutaneous CO2 results can be transmitted by telemonitoring (14) or by patient collecting transcutaneous CO2 monitor or it being couriered to the home with advice on measurement provided by video-or tele-consultation. The equipment is cleaned between patients using isopropyl alcohol cleaning wipes.

In summary, the Expert panel suggests the following precautions:  Disposable equipment is recommended if available.

 A negative nasopharyngeal swab is usually required for full in-lab polysomnography.

Titration studies (Figure 3)  Home PAP treatment initiation using telemonitoring is preferred over in-laboratory testing, in uncomplicated cases (depending on reimbursement policy).

 If patient are eligible for the titration study in the sleep laboratory, proper protective measures due to aerolized generating procedures for patients and for all staff, as well as cleaning precautions for the physical space and equipment, should be introduced.

 Humidifiers are not recommended.

 Use of a non-leaky full face mask with 2 filters added to tubing is recommended.

 Home NIV treatment initiation using capnography is preferred over in-laboratory testing in stable cases.

The COVID-19 lockdown has caused disruption of sleep-activity rhythms in the population, with potential negative consequences on inflammatory and immune mechanisms (15) (16) . The effects of the lockdown on patients already on PAP treatment are currently unknown. An interesting pro-con debate (17) (18) summarized the risks associated with interrupting or continuing home PAP/NIV treatment during the lockdown phase. However, according to a French study, adherence to PAP/NIV treatment increased during the lockdown, possibly due to staying at home and/or a higher perception of risk of developing respiratory disease (19) . In the current phase, it has been suggested that patients should continue home treatment (4).

The transmission of COVID-19 by the patient to his/her relatives at home during PAP treatment is a potential problem. Recommendations on this point are variable, given the sharing of common spaces at home by people in the family.

 In case of fever or respiratory infection, the patient should sleep in a separate room until resolution of symptoms or the results of PCR for COVID-19.

 Use of the humidifier is not indicated under such circumstances, since it may increase droplet and aerosol generation.

 If use of non-vented mask is preferred, an antibacterial/viral filter should be placed between the mask or tracheostomy and expiratory leak (or exhalation port). In some patients (adults and children) the added resistance from the filter can affect comfort. An exhalation valve may offer less resistance than a fixed leak. Close monitoring of arterial oxygen saturation and PaCO2 is required, and the filter should be changed regularly. 

 Sleep studies should be performed for pediatric patients whose care will be affected/delayed if a sleep study is not performed.

 Children should be accompanied by one caregiver during the sleep study.  Home respiratory polygraphy and PAP initiation may be suitable in some selected cases.

The COVID-19 pandemic has urged European Health services to adjust procedures in order to increase safety. This is especially true and requires a cautious and flexible approach in the current phase of increasing COVID-19 cases throughout Europe. Use of telemedicine for SDB would be ideal for many patients, but needs to be implemented and reimbursed in many European countries before its use becomes established at large. Our views have rapidly changed regarding use of telemedicine, since previous studies mainly addressed questions regarding early identification of problems or adherence to PAP treatment, whereas safety was not an issue (27) . Conversely, during the COVID-19 pandemic, telemedicine has been used to effectively provide patient care while limiting the risk of infection. A recent survey on how Sleep Medicine practices were affected by COVID-19 in USA reported that the use of telemedicine and video-consultation increased from less than 25% to over 50% during the pandemic (28) . In addition, while in-laboratory testing decreased, use of home sleep apnea testing was maintained by most laboratories (28) . Patient preferences indicated that patients rapidly adapted to the emerging needs associated with lockdown or limitations in mobility associated with the pandemic (28) . Use of telemedicine produced a faster change in practice in USA compared to Europe, possibly explained by: more uniform regulations throughout USA, a strong action of AASM towards implementation of telemedicine, and the larger flexibility of a private health system compared to the mostly public European health systems.

Diagnosis of SDB underwent some changes after the COVID-19 lockdown. A recent provocative paper questioned the absolute need to perform polysomnography in all patients (29) . Home management of OSA has been shown to be cost-effective, with similar clinical results as those obtained by traditional management, especially in patients with high pre-test probability of OSA (30) . Use of home sleep tests may be a good alternative also for pediatric sleep studies, and the field is moving its first steps towards this direction (31) . In the future, a fully developed "Virtual Sleep Laboratory" may become a reality using video-consultation and home sleep studies to diagnose SDB, titrate settings, problem-solving when patients run into difficulties, and assessment of efficacy of treatment and adherence. Although a significant number of patients will require face to face contact, physical investigation of upper airway anatomy and dental status, and traditional sleep studies for optimal patient care and support, shifting towards a new paradigm of care would be especially vital at the time of COVID-19 pandemic. Since etechnology is already available, the challenge will be to put in practice new management models, with advantages for both patients and specialists, while maintaining a high level of care. Many studies have used telemedicine in OSA management, and showed its highest advantage at the start of CPAP treatment, when problems often arise and patients need additional support, with improved adherence to treatment (32) (33) . However, we should go beyond the remote monitoring of treatment, to develop a new model of comprehensive care for patients on home PAP/NIV (34) .

Alternative treatment for OSA should also be considered, such as oral appliances (OA). Schwartz and coworkers suggested that OA should be first-line treatment during the pandemic, because of its safety (35) . Tanaka & Almeida have developed a set of precautions, including telemedicine, to optimize dental treatment for SDB in full safety (36) .

The COVID-19 pandemic has profoundly changed the setting and attitudes of both patients and health professionals, and its foreseen duration for many months will provide the time for changes to become stable. A major problem is to guarantee access to care for all patients, and elderly or disadvantaged minorities may experience gaps, i.e. in access to services and technology, and this is a problem to be addressed for the new setting to be effective. We need e-health services that are friendly, easy-to-use, cost-effective and easy to access.

An interesting issue in the diagnosis of SDB is the development of safer sensors, for example the nasal cannulas incorporating viral filters (not commercial availability yet), or disposable diagnostic equipment, which may effectively increase safety of the patients, now and after the pandemic will be over.

Although respiratory inductive plethysmography (RIP) may help to diagnose respiratory events without using sensors on the patient's face, it is unlikely to replace traditional sensors for airflow, due to relative instability of signals over time, and lack of sensitivity especially in mild cases. Some solutions have been proposed, such as viral filters inserted in the nasal cannula circuit (37) , or combination of RIP and tracheal sounds (38) . Finally, many smartphone apps may turn out to be useful for SDB diagnosis, but they are not validated yet.

For home PAP titration, it is advisable to use a PAP machine that can be assigned to the patient at prescription. Some laboratories have developed educational videos to show the patients the practical details of mask positioning and use of the PAP device at home, as well as troubleshooting of the most common problems encountered at the start of treatment.

When the sleep study in the laboratory is absolutely necessary, as could be the case in both adults and children, a COVID-19 test is commonly requested, to protect both patient and staff. . Table 1 reports the suggestions for patient and staff protection developed in the SEPAR document according to the epidemiological phase (5) . Besides the oropharyngeal swab, rapid tests are becoming commercially available, and they could be a useful and rapid alternative to traditional PCR, and a major help especially for pediatric patients.

In the last months, it became clear that pandemic waves will recur, with different impact in different countries. Therefore, while the local epidemiology must be the first variable to consider in adjusting management strategies, flexibility is necessary to adapt the general measures summarized in this article, in conjunction with National recommendations, to the local setting. . Street clothes will not be used and the hospital uniform must be changed and cleaned daily.

Protection 3: FFP2/3 mask, nitrile gloves, surgical gown, hat, glasses/plastic face shields). Street clothes will never be used and the work uniform must be changed daily. It is recommended not to use open masks or circuits, but to use a closed circuit with an antiviral filter turning on the equipment only when it is connected to the patient. Flow-chart summarizing the screening procedures commonly adopted before access to the Sleep Laboratory or Clinic. In the phase of high COVID-19 transmission in the community, access to the Sleep lab is limited to very urgent cases, and may require PCR.

Flow-chart summarizing the diagnostic procedures and precautions. In the phase of high COVID-19 transmission in the community, PCR is usually required if a in-laboratory PSG is considered essential for diagnosis. 

In general each sleep lab should take into account the local epidemiological status, the national mitigation strategies and adapt accordingly. All Guidelines agree on:

• If high incidence of COVID-19 in the community, no access to the sleep lab.

Prioritization of tele-consultation and/or telemedicine, with few (mainly urgent) face-to-face consultations.

Assessment of patients prior and at the time of the appointment for temperature, COVID-19 symptoms, contact history and testing status.

General precautions to avoid crowding of patients in the waiting room.

General protective measures for patients and staff (surgical or FFP2 masks, nitrile gloves). In case of countries with high community spread of COVID-19, sleep labs may be closed for visits (3, 4) .

Sleep apnoea management in Europe during the COVID-19 pandemic: data from the European Sleep Apnoea Database (ESADA)

COVID-19 mitigation strategies for sleep clinics and sleep centers -REOPENING

Restoring Pulmonary and Sleep Services as the COVID-19 Pandemic Lessens: From an Association of Pulmonary, Critical Care, and Sleep Division Directors and

Helping Canadian health care providers to optimize Sleep Disordered Breathing management for their patients during the COVID-19 pandemic

Recommendations in a descaling period after the COVID-19 pandemics for sleep and non-invasive mechanical ventilation. Role of Intermediate Respiratory Care Units (UCRIS)

Sleep Breathing Disorders in the COVID-19 Era:Italian Thoracic Society Organizational Models for a Correct Approach to Diagnosis and Treatment

Position Paper for the State-of-the-Art Application of Respiratory Support in Patients with COVID-19

Association for Respiratory Technology and Physiology (ARTP) COVID19 Group

Home sleep testing in the era of COVID-19: a community perspective

Evaluation of droplet dispersion during non-invasive ventilation, oxygen therapy, nebuliser treatment and chest physiotherapy in clinical practice: implications for management of pandemic influenza and other airborne infections

Protecting healthcare workers from SARS-CoV-2 infection: practical indications

High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion

Home PAP devices in COVID-19 infected patients

Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial

Effects of covid-19 lockdown on human sleep and rest-activity rhythms

Putative contributions of circadian clock and sleep in the context of SARS-CoV-2 infection

COVID-19:community CPAP and NIV should be stopped unless medically necessary to support life

Case for continuing community NIV and CPAP during the COVID-19 epidemic

Impact of COVID-19 lockdown on adherence to continuous positive airway pressure (CPAP) by obstructive sleep apnoea patients

Potential influences of obstructive sleep apnea and obesity on COVID-19 severity

Does obstructive sleep apnea lead to increased risk of COVID-19 infection and severity?

ERS statement on obstructive sleep disordered breathing in 1-to 23-month old children

Obstructive sleep disordered breathing in 2-to 18-year old children: Diagnosis and treatment

American Academy of Sleep Medicine Position Paper for the Use of a Home Sleep Apnea Test for the Diagnosis of OSA in Children

Cardiorespiratory sleep studies at home: experience in research and clinical cohorts

Paediatric sleep resources in Canada: The scope of the problem

Telemedicine in the diagnosis and treatment of sleep apnoea

The impact of the COVID-19 pandemic on sleep medicine practices

The COVID-19 Pandemic Presents an Opportunity to Reassess the Value of Polysomnography

Effectiveness of three sleep apnea management alternatives

Is It Time to Head Home for the Night? Home Sleep Testing in Young Children

Effect of telemedicine education and telemonitoring on continuous positive airway pressure adherence. The Tele-OSA Randomized Trial

Telemedicine for continuous positive airway pressure in sleep apnea. A randomized, controlled study

New organisation for follow-up and assessment of treatment efficacy in sleep apnoea

Oral appliance therapy should be prescribed as a first-line therapy for OSA during the COVID-19 pandemic

What can a dentist and dental sleep apnea researcher do under COVID-19 lockdown?

Safe sleep apnea tests during Covid-19 pandemic: a new practical proposal

Diagnosis of sleep apnea without sensors on the patient's face

All Guidelines agree on: Home sleep testing is preferred over in-laboratory testing in many countries.  Limitation of in laboratory PSG to urgent and high risk patients in most countries.  Assessment prior and at time of the in-person appointment for COVID-19 (symptoms, contact history, or questionnaire).  General precautions to avoid crowding of patients in the waiting room.  General protective measures for patients and staff (surgical or FFP2 masks, nitrile gloves).  Disposable probes, if available in most countries. The sleep test device, sanitized after each use, should not be used for at least 72 h before use in another patient.  Screening of patients and personal staff by swab in many countries, based on COVID-19 epidemiological status and availability of the test.

 For diagnostic study scheduling, age and comorbidities are taken into account in Spain (5) , Italy (6) and USA (2, 3) . Although in most countries home sleep testing is preferred, in Germany PSG remains the preferred diagnostic test (7) . In UK (8) and Italy (6) limited sleep test methodology is used besides cardiorespiratory polygraphy. In USA the options of pickup/return of equipment by the patients, or a home delivery service, are suggested. The use of nasal cannulas is not recommended in Italy (6); instead respiratory inductive plethysmography (RIP) is suggested for the identification of respiratory events.  General precautions to avoid crowding of patients in the waiting room are stricter in UK (8) and USA (2, 3) , based on available sleep lab facilities to minimise face to face contact and guarantee sufficient air exchange of the room. In case of high community spread of COVID-19 (4, 6) , in-laboratory PSG is usually postponed or PCR is required.

All Guidelines agree on:  Home PAP and NIV treatment initiation using telemonitoring (5, 8) . Humidifiers are usually not recommended during titration (5, 6, 8) .

Disposable probes are recommended if available (2, 5, 8) . Use of a non-leaky full facemask with a filter added to the tubing is suggested in many countries.  Equipment should be sanitized according to the manufacturer's instructions.

Follow up with telemedicine is preferred in most countries.  General protective measures for patients and staff (FFP3 masks, nitrile gloves, glasses).

In Germany fewer restrictions for in lab titrations and in-person visits (7) . In U.S.A. and Italy (urgent cases), in lab titrations are permitted if they take place in an airborne infection isolation room (2, 6) . In Spain (5) Similarities  General protective measures for patients and staff, according to national guidelines.  New PAP prescriptions should be limited or delayed and restricted to urgent cases, apart from Germany. In U.S.A. there is an exception if it takes place in an airborne infection isolation room.  Home PAP treatment initiation using telemonitoring is preferred in many countries.  Humidifiers are usually not recommended. Use of a non-leaky full facemask with a filter added to the tubing in many countries if available.  Equipment disinfected according to the manufacturer's instructions.  Follow up with telemedicine is preferred in most countries, except Germany.

In Spain and U.S.A., empirical treatment with delayed diagnostic testing could be considered in high risk cases.  +/-Negative PCR 48h before the study in Spain and U.S.A, negative PCR in Germany before access to hospitals. In case of countries with high community spread of COVID-19, such as Italy, sleep labs are still closed for visits or in the early opening phase.On the other hand, in Germany fewer restrictions, with in lab titrations and in-person visits. In U.S.A. and Italy (urgent cases) in lab titrations are permitted if they take place in an airborne infection isolation room.In U.S.A. and Italy (urgent cases) in lab titrations are permitted if they take place in an airborne infection isolation room.