# Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea

Fanny Bertelli, Carey Suehs, Jean-Pierre Mallet, Isabelle Court-Fortune,
Frédéric Gagnadoux, Jean-Christian Borel, Olivier Gaubert, Nicolas Molinari,
Arnaud Bourdin, Dany Jaffuel

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Fanny Bertelli, Carey Suehs, Jean-Pierre Mallet, Isabelle Court-Fortune, Frédéric Gagnadoux, et al. Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea. Respiratory Research, 2022, 10.1186/s12931-022-01969-z. http://03618302v2

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# Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea

Fanny Bertelli¹,², Carey M. Suehs¹,<fnref n="3" /> ID, Jean-Pierre Mallet<fnref n="3" />,⁴, Isabelle Court-Fortune⁵ ID, Frédéric Gagnadoux⁶ ID, Jean Christian Borel⁷ ID, Olivier Gaubert², Nicolas Molinari¹, Arnaud Bourdin<fnref n="3" />,⁴ ID and Dany Jaffuel²,<fnref n="3" />,⁴* ID

**Abstract**

**Background:** Whether the COVID-19 pandemic impacts Positive Airway Pressure (PAP) adherence over the long-term is unknown and only preliminary short-term data have been reported.

**Methods:** With the aim of describing the impact of the first and second waves of COVID-19 on PAP adherence during 2020 in France, we designed a cross-sectional study of Sleep-Apnea (SA)-patients under PAP telemonitoring. To examine PAP adherence in adult SA patients, we assessed de-identified data from a non-profit healthcare provider database during the period January 1, 2019 to December 31, 2020. Included patients met the following criteria: (i) PAP-treated for at least 4 months before January 1, 2019 and with continuous PAP during both 2019 and 2020; (ii) ≥ 360 daily PAP telemonitored data per year. For PAP adherence, data were collected using the PAP-software.

**Results:** 8477/10482 patients were finally included in the analysis [72.4% male, median age 70 years (IQ₂₅⁻₇₅: 61–77], 25.6% < 62 years old, initial Apnea–Hypopnea Index (AHI) of 41 (31–59)/h. Median PAP adherence was 7.21 (6.12–8.10) h/day in 2020 versus 7.12 (6.05–8.02) h/day in 2019, p < 0.001. The median difference in PAP adherence between the first 2020 lockdown and the corresponding 2019 weeks was 9.75 (CI₉₅% 8.75–10.75) min/day, p < 0.001. The median difference in PAP adherence between the second 2020 lockdown and the corresponding 2019 weeks was 5.00 (CI₉₅% 4.00–6.00) min/day, p < 0.001. If we consider the minimal clinically important difference of 30 min for PAP adherence, 30.4% and 26% of the patients increased their PAP adherence by at least 30 min during the first and second lockdowns respectively; 17.6% and 19.3% of the patients lowered their PAP adherence by at least 30 min in the first and second lockdowns, respectively.

**Conclusion:** During the first and second lockdowns, the COVID-19 pandemic had a clinically irrelevant effect on PAP adherence for the study population. Future studies are needed to describe COVID-19 pandemic impact on PAP adherence not only for long-term PAP-treated SA patients but also for incident cases.

*Trial registration* The COVADENE study was registered on March 1st, 2021 on [ClinicalTrials.gov](https://ClinicalTrials.gov) (Identifier: NCT04775966)

**Keywords:** Sleep Apnea, CPAP, COVID 19, And adherence

**Background**

For sleep apnea (SA) patients, despite advances in alternative therapy, Positive Airway Pressure (PAP) remains the cornerstone of treatment [1], improving daytime sleepiness, sleep quality and quality-of-life proportional to PAP adherence [2, 3].

<footnote>*Correspondence: dany.jaffuel@wanadoo.fr</footnote>

<footnote n="3">³ Department of Respiratory Diseases, Univ Montpellier, CHU Montpellier, 371, Avenue Doyen Giraud, 34295 Montpellier Cedex 5, France
Full list of author information is available at the end of the article</footnote>
How the COVID-19 pandemic alters sleep is currently under investigation. Among SA patients, many are at increased-risk for lethal COVID-19 infection due to commonly occurring SA-comorbidities. For PAP-treated patients, additional stress also results from controversial proposals to continue or stop PAP treatment due to the supposed increased risk of COVID-19 infection associated with PAP-flow [4–6].

As recently underlined by a perspective article [7] and a review article [8], whether the COVID-19 pandemic impacts PAP adherence over the long-term is unknown and only preliminary data on the initial 4 weeks of the first lockdown have been reported [9–11]. With the aim of describing the impact of the first and second waves of COVID-19 on PAP adherence during 2020 in France, we designed a cross-sectional study of SA patients under PAP telemonitoring and compared 2020 versus 2019 PAP adherence.

# Methods

## Study design

The COVADENE study was approved by the Montpelier University Hospital Institutional Review Board (reference number IRB-MTP_2021_01_202100723) and registered on ClinicalTrials.gov (NCT04775966). To examine PAP adherence in adult SA patients, we assessed de-identified data from a non-profit healthcare provider database (ADENE group) during the period January 1, 2019 to December 31, 2020. Included patients met the following criteria: (i) treated for SA syndrome (i.e., an initial polygraphy or polysomnography Apnea–Hypopnea Index (iAHI) ≥ 30/h or iAHI ≥ 15/h (and more than 10/h respiratory-effort-related arousal or cardio-metabolic/ respiratory comorbidities) associated with three symptoms among sleepiness, tiredness, snoring, headaches, hypertension, reduced vigilance, libido disorders, nocturia, choking or suffocation during sleep); (ii) PAP-treated for at least 4 months before January 1, 2019 and with continuous PAP during both 2019 and 2020; (iii) acceptance of PAP telemonitoring with consent given for data collection and anonymization; (iv) ≥ 360 daily PAP tele monitored data per year for both 2019 and 2000. Using electronic records, information on age, sex, and initial AHI was collected. For PAP adherence, data were collected using the PAP-software. PAP adherence was expressed in hours/day and a PAP adherent patient was defined as a patient with a PAP adherence ≥ 4 h/day per week.

## Statistical analyses

For statistical analyses, continuous data were presented as medians with their associated quartile ranges due to non-Gaussian distributions. Qualitative parameters were

presented as numbers and percentages. Continuous variables were compared using Wilcoxon tests (for paired data), and qualitative ones using McNemar tests.

Multivariable logistic regression analyses (MLRA) were used to study associations between explanatory variables [age < 62 years (reflecting the age of professional retirement in France), sex (women) and iAHI ≥ 30/h] and two variables of interest (PAP adherence increase by at least 30 min and PAP adherence decrease by at least 30 min, PAP adherence measured in the first or second lockdown weeks minus the corresponding 2019 weeks). The explanatory variables were systematically fed into multivariable analyses. The two variables of interest were chosen because of the minimal clinically important difference (MCID) of 30 min for PAP adherence [1]. All statistical analyses and figures were performed using R Statistical Software (version 4.0.2 R Foundation for Statistical Computing, Vienna, Austria).

# Results

Of the 10,482 patients in the database, 8477 patients respecting the inclusion criteria were finally analysed. The 8477 patients (72.4% male) had a median age of 70 years (IQ$_{25–75}$: 61–77), 25.6% were < 62 years old, and the median AHI was 41 (31–59)/h.

Figure 1 depicts the median PAP adherence (h/day) per week and the median proportion of adherent patients per week for 2019 (panel A) and 2020 (panel B). Median PAP adherence was 7.21 (6.12–8.10) h/day in 2020 versus 7.12 (6.05–8.02) h/day in 2019, p < 0.001. The median difference in PAP adherence between the first 2020 lockdown and the corresponding 2019 weeks was 9.75 (CI$_{95\%}$ 8.75–10.75) min/day, p < 0.001. The median difference in PAP adherence between the second 2020 lockdown and the corresponding 2019 weeks was 5.00 (CI$_{95\%}$ 4.00–6.00) min/day, p < 0.001. Baseline variability in PAP adherence was measured for the first 4 weeks of each year. A difference (2020 – 2019) was observed with a median deviation of 1.50 min (CI$_{95\%}$ 0.50; 2.50), (p = 0.008).

If we consider the MCID of 30 min for PAP adherence [1], 30.4% and 26.0% of the patients increased their PAP adherence by at least 30 min during the first and second lockdowns, respectively, in comparison with their analogous 2019-weeks. Multivariable logistic regression analysis (MLRA) suggests: (i) for the first lockdown, only “age < 62 years” was considered a significant explanatory variable (odds ratio (OR) 1.68 (1.51–1.86), p < 0.001; (ii) for the second lockdown, “age < 62 years” and “women” remained significant [OR 1.30 (1.17–1.45), p < 0.001, OR 1.29 (1.16–1.43), p < 0.001, respectively].

On the contrary, 17.6% and 19.3% of the patients lowered their PAP adherence by at least 30 min in the first
<figure><img src="image_3.png" /><figcaption>**Fig. 1** Median PAP adherence (h/day) per week and the proportion of adherent patients per week for the year 2019 (A) and 2020 (B)</figcaption></figure>

and second lockdowns, respectively, in comparison with their analogous 2019-weeks. MLRA suggests that only “women” remained a significant explanatory variable for the first lockdown [OR = 1.48 (1.31–1.67), p < 0.001], while women (OR = 1.13 (1.00–1.27), p = 0.040) and age < 62 years (OR = 0.87 (0.77–0.99), p = 0.033] remained for the second lockdown. Figure 2 depicts a Sankey diagram for the MCID trajectories in 2020 and particularly during the lockdown weeks.

The percentage of patients with a median adherence > 4 h/day was 93.43% in 2020 and 93.37% in 2019. The percentages of PAP adherent patients during the first and second lockdowns were not significantly higher than in the corresponding 2019 weeks (with differences of 0.52% and 0.18%, p = 0.0692 and p = 0.5538, respectively). Considering the 12,038 patients treated with PAP for at least 4 months on January 1, 2019, 5.36% stopped PAP therapy in 2019 versus 4.10% in 2020 (p < 0.001). In addition, 188 patients died (1.56%) in 2019 versus 211 (1.88%) in 2020 (p = 0.007).

Other circumstantial events, such as the 2019 heat wave in Europe and 2019/2020 New Year celebrations, impact PAP adherence. The median difference in PAP adherence between the 2020 weeks and the corresponding 2019 heat wave weeks was 11 min/day (– 18 min and

45 min for Q1 and Q3, respectively). The median difference in PAP adherence between the 2020 and 2019 New Year celebration days was 3 min (– 32.5 min and 44 min for Q1 and Q3 respectively).

## Discussion

To our knowledge, this study is the first to describe the impact of the COVID-19 pandemic on the PAP adherence of SA patients for the entire 2020 year. In contrast with three previous studies reporting on only the 4 first weeks of the first lockdown [9–11], we report a two-phase curve for PAP adherence on the full first lockdown duration. As a consequence, we report only a 1.44% median increase (p < 0.001) in PAP adherence (6.25 min) for the full first lockdown in comparison with the 4 weeks preceding the lockdown.

In the COVADENE study, we report a median increase of 5 min (p < 0.001) when comparing PAP adherence between 2020 and 2019. It is important to underline that: (i) for the whole population, this statistically significant difference is largely under the MCID of 30 min [1]; (ii) this difference is not exclusively related to the COVID-19 pandemic but also the consequence of circumstantial events like the 2019 heat wave in Europe. PAP adherence is known to worsen during the summer [12] and
<figure><img src="image_4.png" /></figure>

we can reasonably speculate that heat waves do not cre-
ate favorable conditions for PAP adherence. In our opin-
ion, the increase in 2020 versus 2019 PAP adherence for
weeks 26 to 30 seems to be more the consequence of
the 2019 heat wave rather than the consequence of the
COVID 2019 pandemic. Other circumstantial events,
such as New Year celebrations, also impact PAP adher-
ence on a whole population basis. In our study popula-
tion, the last 7 days of either year are associated with a
fall in both PAP adherence and the percentage of adher-
ent patients was lower in 2020 (not only because of a
curfew but also because of a French state policy not to
celebrate the New Year).

As a result of these observations, the 2020 PAP adher-
ence of our SA-population appears to be influenced
by a combination of factors, including COVID-19. It
can be assumed that the impact of COVID-19 on SA-
patient sleep is also influenced by the country they live
in, not because of the health care system characteristics
for SA-patient management but rather because of cul-
tural and sociological parameters. In our results, peo-
ple still in professional activity (age <62) could have had
less social jetlag and thus improved their sleep duration
and PAP adherence [13]. As an example using crowd-
sourced smartphone data for non SA-populations, recent
publications have described an average increase in sleep
duration of 4.9 to 20 min (18.3 min for France) during
the initial lockdown weekdays [13–15]. During the first

lockdown, in an Italian population, a gender-depend-
ent effect of COVID 19 pandemic on sleep quality was
reported [16]. In this study, additional lockdown-related
stress such as taking care of children and other family
duties were hypothesized to explain women's probability
of developing sleep problems.

Limits of the study

Our population was treated in France on a long-term
basis and our conclusions may not be applicable to short-
term and/or other countries.

Because of the study design and data collection, we
were unable to include more than three potentially expli-
cative variables in the multivariable logistic regression
analyses, and obviously important variables (such as
comorbidities, residual sleepiness, and partner presence)
were unavailable.

Conclusions

During the first and second lockdowns, the COVID-
19 pandemic had a clinically irrelevant impact on PAP
adherence for the study population. The 2020 PAP
adherence of our SA-population appears to be influ-
enced by a combination of factors, including COVID-
19. The reader should also keep in mind that our
observations are limited to long-term treated patients.
Future studies are needed in other countries to describe
the COVID'19 pandemic impact on PAP adherence not only for long-term PAP-treated SA patients, but also for incident cases.

### Abbreviations

AHI: Apnea-Hypopnea Index; iAHI: Initial Apnea-Hypopnea Index; MCID: Minimal clinically important difference; MLRA: Multivariable logistic regression analyses; PAP: Positive Airway Pressure; SA: Sleep-Apnea.

### Acknowledgements

The authors would like to thank the ADENE team for their help in carrying out this study (administrative Team: Pierre Coulot, Sophie Laffite and Valérie Bachelier; expert Team; Raphael Gilson, Christian Martinez, Joël Nogue and Magali Partyka).

### Authors' contributions

DJ had access to the data and takes responsibility for the integrity and accuracy of the analysis. FB: study design, data collection, analysis, and manuscript preparation; CMS: analysis and manuscript preparation; JPM, ICF: study design and manuscript preparation; FGD, JCB: manuscript preparation; OG: data collection; NM, AB, DJ: study design, analysis, and manuscript preparation. All authors contributed to the final submitted manuscript. All authors read and approved the final manuscript.

### Funding

The authors have no support nor funding to report in relation with the present study.

### Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

### Declarations

#### Ethics approval and consent to participate

The COVADENE study is registered on ClinicalTrials.gov (Identifier: NCT04775966). The protocol complied with the Declaration of Helsinki and was reviewed and approved by the Montpellier University Hospital Institutional Review Board (reference number IRB-MTP_2021_01_202100723).

#### Consent for publication

Not applicable.

#### Competing interests

Dr. Suehs reports grants and fees from AstraZeneca, a grant from GSK, outside the submitted work. Dr. Mallet reports personal fees from ADENE, outside the submitted work. Dr. Court-Fortune reports grants and personal fees from NOVARTIS, grants and personal fees from ASTRA ZENECA, grants and personal fees from SANOFI, grants and personal fees from GSK, grants and personal fees from BOEHRINGER INGELHEIM, outside the submitted work. Pr. Gagnadoux reports grants and personal fees from RESMED, personal fees and non-financial support from SEFAM, personal fees from CIDELEC, personal fees and non-financial support from NOVARTIS, personal fees from ACTELION, non-financial support from BOEHRINGER INGELHEIM, personal fees and non-financial support from NYXOAH, non-financial support from ASTEN, outside the submitted work. Dr. Jean Christian Borel reports grants and personal fees from Philips, salaries from AGIR à dom, personal fees and other from RESMED, other from NOMICS, outside the submitted work. Pr. Bourdin reports grants, personal fees, non-financial support and other from GSK, grants, personal fees and other from Astra Zeneca, grants, personal fees and other from Boehringher Ingelheim, grants, personal fees and other from Novartis, grants, personal fees and other from Chiesi Farma, grants, personal fees and other from Teva, other from PneumRx, personal fees and other from Actelion, grants from Merck, outside the submitted work. Dr. JAFFUEL reports personal fees from Philips Healthcare, personal fees from Resmed, personal fees and non-financial support from SEFAM, personal fees from Lowenstein, personal fees from GSK, personal fees from Boehringher Ingelheim, personal fees from Jazz, grants and personal fees from Novartis, personal fees from Astra Zeneca, personal fees

from Chiesi Farma, personal fees from SANOFI, outside the submitted work. FB, OG, NM, report no conflicts of interest in relation to the present work.

### Author details

¹Department of Medical Information, Montpellier University Hospital, IDESP, UMR 5149, Montpellier University, 34090 Montpellier, France. ²Groupe Adène, rue de Chambert, 34080 Montpellier, France. ³Department of Respiratory Diseases, Univ Montpellier, CHU Montpellier, 371, Avenue Doyen Giraud, 34295 Montpellier Cedex 5, France. ⁴PhyMedExp, CNRS, INSERM, Univ Montpellier, CHU Montpellier, Montpellier, France. ⁵Department of Respiratory Diseases, CHU Saint Etienne, 25, boulevard Pasteur, 42055 Saint-Étienne Cedex 2, France. ⁶Department of Respiratory and Sleep Medicine, Angers University Hospital, INSERM U1063, SOPAM, Angers University, Angers, France. ⁷Inserm U1042, HP2 (Hypoxia PhysioPathology), Laboratory Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Alps, University, Grenoble, France.

Received: 16 August 2021 Accepted: 22 February 2022

Published online: 04 March 2022

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