Ann: ResApp announces FDA 510(k) submission for SleepCheckRx, page-74

Sleep studies around the world have been affected by Covid for obvious reasons ....Sleep Check is due for FDA approval decision any time after 90 day review process, which is 11th January 2022

Sleep Check by prescription is a massive opportunity for Resmed and Phillips in the USA to regain the loss in sleep studies that have been placed on hold globally.

During Covid sleep studies have been placed on hold.   I believe there is a massive opportunity for Sleep Check by prescription in USA.  

It is being reported that sleep disturbance is a massive problem world wide because of Covid.

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

• Karin G. Johnson, MD,
  
• Shannon S. Sullivan, MD,
  
• Afua Nti, BA,
  
• Vida Rastegar, MPH,
  
• Indira Gurubhagavatula, MD, MPH

Published Online:January 1, 2021https://doi.org/10.5664/jcsm.8830Cited by:15

ABOUT
ABSTRACT

STUDY OBJECTIVES:
The COVID-19 pandemic required sleep centers to consider and implement infection control strategies to mitigate viral transmission to patients and staff. Our aim was to assess measures taken by sleep centers due to the COVID-19 pandemic and plans surrounding reinstatement of sleep services.


METHODS:
We distributed an anonymous online survey to health care providers in sleep medicine on April 29, 2020. From responders, we identified a subset of unique centers by region and demographic variables.


RESULTS:
We obtained 379 individual responses, which represented 297 unique centers. A total of 93.6% of unique centers reported stopping all or nearly all sleep testing of at least one type, without significant differences between adult and pediatric labs, geographic region, or surrounding population density. By contrast, a greater proportion of respondents continued home sleep apnea testing services. A total of 60.3% reduced home sleep apnea testing volume by at least 90%, compared to 90.4% that reduced in-laboratory testing by at least 90%. Respondents acknowledged that they implemented a wide variety of mitigation strategies. While no respondents reported virtual visits to be ≥ 25% of clinical visits prior to the pandemic, more than half (51.9%) anticipated maintaining ≥ 25% virtual visits after the pandemic.


CONCLUSIONS:
Among surveyed sleep centers, the vast majority reported near-cessation of in-laboratory sleep studies, while a smaller proportion reported reductions in home sleep apnea tests. A large increase in the use of telemedicine was reported, with the majority of respondents expecting the use of telehealth to endure in the future.


CITATION:
Johnson KG, Sullivan SS, Nti A, Rastegar V, Gurubhagavatula I. The impact of the COVID-19 pandemic on sleep medicine practices. J Clin Sleep Med. 2021;17(1):79–87.




BRIEF SUMMARY
Current Knowledge/Study Rationale: To understand changes in sleep medicine practices due to COVID-19, we distributed an anonymous online survey to sleep medicine health care workers and received 397 responses, primarily from sleep technologists and physicians, at 297 unique centers.

Study Impact: The vast majority of respondents reported implementing radical changes to their practices, with 93.6% of centers reporting cessation of all or nearly all sleep testing of at least one type. Pediatric studies (82.2%) and home sleep apnea testing services (60.3%) were less frequently discontinued or reduced. Centers reported utilizing a variety of mitigation strategies. Though rarely used prior to the pandemic, virtual visits were frequently implemented, and 51.9% of respondents anticipate that ≥ 25% of their encounters will continue to occur through telemedicine after the pandemic.




INTRODUCTION
The coronavirus disease 2019 (COVID-19) pandemic, a result of the novel coronavirus SARS-CoV-2, has demanded that health care practices adapt quickly to limit the possible spread of this infection, which has caused tremendous morbidity and mortality worldwide. Although the spread of the virus was deemed to occur largely through infectious droplets of varying sizes, evidence demonstrating viral existence in aerosol droplets in room air samples has raised questions regarding aerosol transmissibility. Both the World Health Organization and the Centers for Disease Control (CDC) acknowledged the potential for viral transmission via “aerosol-generating procedures,” including noninvasive ventilation such as positive airway pressure (PAP) therapy and high-flow oxygen.1–6 Such advisories resulted in sudden disruption in the provision of health care services, with recommendations by some professional societies to stop certain elective services entirely, such as upper airway surgeries.7 The CDC emphasized the role of social distancing as a vital measure in mitigating the risk of viral transmission.8

Diagnostic testing for sleep-related respiratory disorders and therapies utilizing PAP are widely utilized in the sleep medicine field and constitute gold standard care in many cases. Patients receiving such services often have comorbidities associated with risk of severe COVID-19, including obesity, hypertension, and diabetes mellitus.9 Therefore, the COVID-19 pandemic inflicted immediate challenges for the safe provision of these core diagnostic and therapeutic services.

In response, the American Academy of Sleep Medicine (AASM) published guidance on March 19, 2020, regarding mitigation strategies for the spread of COVID-19 in sleep practices.10 Updated on April 8, 2020, this document recommended postponement and rescheduling of in-laboratory polysomnography and PAP administration except in emergencies, with continued postponement of all other nonurgent care until at least April 30. This recommendation resulted in the closure of many attended sleep laboratories and a reduction in home sleep apnea testing (HSAT), but the extent of the response to and consistency with these recommendations across regions remained unknown. Follow-up recommendations about mitigation strategies to consider when reopening laboratories was published on April 27, 2020.11

Clinical care was also heavily affected by limitations on face-to-face visits. The use of virtual platforms to provide clinical care for patients with sleep disorders has existed for nearly 2 decades and has been rising recently.12 The AASM has defined key standards with regard to its application.12 Although data suggest that telemedicine in sleep medicine may improve adherence to PAP,13 and increase efficiency of care14 while maintaining patient satisfaction,15 use of sleep telemedicine remained limited by lack of payer coverage, state licensing restrictions, and specific payer requirements for face-to-face visits. During the COVID-19 pandemic, however, many insurance providers, including the Centers for Medicare Services, have increased coverage for phone and video virtual visits, waived face-to-face requirements, and permitted provision of care across state lines during the COVID-19 pandemic.16

To understand the extent of the COVID-19 pandemic’s impact on sleep medicine health care services, we surveyed a broad range of individuals working in this field regarding closure of sleep diagnostic laboratories, policies for screening patients for COVID-19, strategies to guide laboratory reopening, and other opinions regarding procedures implemented to mitigate viral transmission in the acute stages of the pandemic. We hypothesized that regional differences in the changes of practice may relate to the degree of local COVID-19 transmission.


METHODS

Study design
On April 29, 2020, we distributed the link to a 139-item, anonymous, and confidential survey to a large group of health care workers in sleep medicine by electronic mail using distribution lists provided by the American Academy of Sleep Medicine’s weekly bulletin (n = 7,609 recipients). The link was also posted on the American Academy of Neurology sleep medicine Synapse group as well as on several physician and sleep technologist Facebook groups, and could also be shared through word-of-mouth using email or social media accounts. The Tufts Research Electronic Data Capture platform housed the survey designed with branching logic based on provider and sleep study types.17 Only some demographic responses were mandatory, and no personal identifying information was requested. For example, providers were asked questions only about their clinics and telemedicine. The protocol and survey were submitted to the Institutional Review Board of Baystate Medical Center and determined to be exempt from review. The link was active from April 29, 2020, through May 8, 2020.


Survey development
The survey was developed based on clinical experience of sleep medicine physicians who were working in the northeast, midwest, and West Coast of the United States, near regions that were then experiencing a high or increasing prevalence of COVID-19. A draft version of the survey was created by the author (KJ), who then solicited input from an expert panel including representatives from AASM, American Academy of Sleep Technologists, and other practicing sleep experts (see Acknowledgments). Co-authors IG and SS served on the AASM Public Safety Committee and helped write AASM’s COVID-19 mitigation strategies. Group consensus was used to structure the questions. Through interactive discussions and review of current Centers for Disease Control and AASM recommendations, the group prioritized key areas of assessment, including: (1) use of telemedicine; (2) reduction of lab services; (3) transmission concerns; (4) preferred mitigation strategies; and (5) anticipated reopening strategies. The wording and formatting of the survey questions were further revised by a research team member with experience in survey design at Baystate Medical Center to enhance readability.


Participants
Health care providers in sleep medicine were the intended respondents.


Data collected
We collected demographic variables about the respondents’ sleep laboratories, including country, state, primary laboratory location, laboratory type, number of beds, adult/pediatric, and HSAT use. We also collected information concerning changes in the volume of laboratory procedures and in the adoption of telemedicine during the COVID-19 pandemic, as well as anticipated changes in coming months. The full questionnaire is in the supplemental material.


Inclusion/exclusion criteria
We excluded respondents if they did not fill in survey data beyond the first page (demographics) or had incomplete demographic data. Surveys that were incomplete otherwise were still included. We created a “unique center” cohort by analyzing 7 laboratory characteristics (Table 2). Entries were defined as replicates if they agreed on all 7 variables. When this occurred, we chose the medical director, if available, for inclusion in the unique center cohort. Otherwise, we included the first respondent from the group of respondents presumed to be from the same center in the unique cohort. We used the resulting unique center cohort to mitigate replication bias from multiple respondents from the same laboratory.


Statistical analysis
We reported summary statistics on a participant level as well as the unique cohort level. For data about HSAT or pediatric testing, we limited the responses only to those who reported that their lab performed those type of studies. For calculating sleep study activity rates, we used the appropriate corresponding denominator, based on whether the laboratory performed in-laboratory adult, in-laboratory pediatric, or home studies. We used Fisher’s exact test to compare categorical variables between groups. Significance testing was 2-sided at a critical test level of 5%. All data management and statistical analysis were performed using Stata version 16.0.


RESULTS

Respondents
We received a total of 446 survey responses. We excluded 51 respondents who provided only demographic information and another 16 surveys that were blank. Therefore, we included a total of 379/446 (85%) total respondents in the analysis. A nonresponder analysis confirmed that excluded surveys (n = 51) did not differ significantly in demographics or survey date from those that were included. Our unique center cohort contained n = 297 surveys.

Table 1 summarizes demographic information in all 379 included respondents and 297 respondents in the unique center cohort. In brief, the majority of respondents were either physicians (75, 19.8%) or sleep technologists (283, 74.7%). Other professions included administrative coordinator (1), nontechnologist sleep manager (3), registered nurse (1), registered health care scientist (1), and clinical coordinator (1). Physicians were able to choose multiple subspecialties as their primary specialty and 57 (76.0%) physicians reported sleep medicine as one of their primary specialties. Responses reflected a wide range of experience in sleep medicine, with the majority reporting 10–20 years (162, 58.1%).

All in my opinion
MB