Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study

Abstract

Introduction

Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. However, CPAP termination rates remain very high, and adherence to therapy is a major issue. To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data. The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated. This study aims to obtain solid quantitative results examining the relationship between the determinants of refusal, non-adherence, or termination of CPAP treatment, and in particular the pivotal role played by health literacy.

Methods and analysis

This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of the Grenoble Alpes University Hospital, France. Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. They will benefit from home visits by a CPAP technician or nurse at CPAP initiation. Patients will then be followed up for 6 months through the telemonitoring platform of a home-care provider. The primary objective is to evaluate the impact of health literacy (health literacy, measured by the European Health Literacy Survey questionnaire (HLS-EU-16) on the refusal, non-adherence or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The target sample size is 250 participants.

Ethics and dissemination

The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). All patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes. We will publish the results in a peer-reviewed medical journal and on our institutional websites.

Trial registration number

NCT05385302.

Strengths and limitations of this study.

• A large, transdisciplinary, prospective observational study.

• Performed by a close collaboration among expert teams from social sciences (Social Sciences Research Centre, PACTE, French Observatory of non-recourse to rights and services, ODENORE), clinical research (the Hypoxia and Cardiovascular and Respiratory Physiopathology HP2 laboratory) and a continuous positive airway pressure (CPAP)-telemonitoring provider (Agir à Dom).

• Robust methodology using both quantitative (validated questionnaires) and qualitative data collection (semistructured interviews).

• Patients who refuse to participate in the study could potentially be those who would be more likely to refuse CPAP treatment or who have low levels of health literacy.

• Considering the present insufficient knowledge of the social factors (including health literacy) that influence refusal, non-adherence or termination of CPAP treatment for obstructive sleep apnoea syndrome, a randomised controlled trial is not appropriate.

Introduction

Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that is heterogeneous in its presentation and phenotypes. Its prevalence was recently estimated at more than 900 million people worldwide, including 24 million in France.¹ Due to nocturnal micro-awakenings and intermittent hypoxia, OSAS has a direct impact on quality of life (daytime sleepiness, memory problems, irritability, and reduced social interactions) leading to an increased risk of road and work accidents. OSAS is associated with numerous cardiovascular and metabolic complications.²

Currently, continuous positive airway pressure (CPAP) treatment is the first-line treatment for OSAS. In France, 1.6 million patients are treated with CPAP, but 15% of patients refuse to try the device at the time of diagnosis. Furthermore, the non-adherence rate is 20%–30% after 3 years of treatment.^{3 4} Both in terms of sleepiness⁵ and cardiovascular complications,⁶ clinical improvement is correlated with the normalisation of ventilation and therefore, if possible, the use of CPAP over the entire sleep period and at least 4 hours per night.^7–9 CPAP use can be tracked using telemonitoring, which provides prescribers, home healthcare providers, and patients with daily feedback on adherence, efficacy, and technical problems.¹⁰

To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data (age, sex, severity of OSAS, symptoms, etc)^{11 12} or technical factors directly related to CPAP treatment (type of mask, residual apnoea-hypopnea index (AHI) under treatment, leaks, side effects, etc)¹¹ (for review, see ref. 13).

The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated, although they are gradually gaining interest. For example, it has been shown that social, structural, and environmental determinants of health, such as food or housing insecurity, systemic racism, or chronic stress, account for 60%–80% of the modifiable risk of disparities in marginalised populations.^{14 15} To date, these determinants have been difficult to address systematically because of their heterogeneity and multidimensionality. In the context of OSAS, high individual socioeconomic deprivation was shown to be a significant independent predictor of poor adherence to CPAP.¹⁶ Other studies have focused on psychological factors including self-efficacy, health value, and health locus of control (incorporating internality, chance, powerful others).^{17 18} Recently, we investigated the spouse’s/partner’s involvement and the quality of the couple’s relationship on CPAP adherence.¹⁹ However, these studies target individual determinants, without a comprehensive consideration of clinical, individual lifestyle, and psychosociological determinants. Expanding beyond clinical data and improving knowledge of the individual determinants of CPAP adherence using large-scale person-generated health data is crucial to improve the health and well-being patients diagnosed with OSAS through strategies customised to individual context and need.^{20 21}

The social determinants of health (SDOH) and health literacy (HL) are closely intertwined. HL is defined as ‘the ability to access, understand, evaluate and communicate information in ways that promote, maintain and improve one’s health in various settings throughout life’.^{22 23} Low HL has been consistently associated with poorer ability to interpret labels and health messages, a higher prevalence of risk factors related to health, less effective communication with health professionals, a limited understanding of prescriptions, limited ability to self-manage chronic disease, increased hospitalisations and readmissions, and increased healthcare costs.^{24 25} According to a European study by the Organisation for Economic Cooperation and Development (OECD), the HL skills of the French adult population are among the lowest of all the countries that participated. These results led the French National Health Council to identify HL as one of the major priorities for improving individual health.²⁶ It has been shown that individuals with low levels of HL are at high risk for developing health problems due to poor understanding of information relating to their health.²⁷

A meta-analysis examining the relationship between HL and adherence to both medication and non-medication regiments showed that interventions targeting HL increased both HL and adherence outcomes.²⁸ In the context of sleep disorders, and in particular OSAS, HL has been scarcely explored. An approach implemented in New Zealand highlighted that HL as one of the risk factors for non-adherence to CPAP treatment.¹⁶ However, current applications are limited and there is no multifactorial approach that considers all individual clinical, sociological, economic, and home environment determinants.^{16 29 30}

The present study aims to obtain solid quantitative results on the links between the determinants of refusal, non-adherence or termination of CPAP treatment and in particular, the pivotal role played by HL. These results will be put into perspective based on qualitative data collected during face-to-face individual interviews led by sociologists. The primary hypothesis of this study is that a patient with an insufficient level of HL (ie, a score of less than 9 on the European Health Literacy Survey Questionnaire³¹) has a greater probability of refusing or terminating their CPAP treatment early on or being non-adherent, compared with a patient with a higher HL score.

Methods and analysis

Study design and setting

This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of Grenoble Alpes University Hospital, France and the Sleep Health Centre, Grenoble France, between 30 September 2022 and 31 December 2024. The study is based on a collaboration between the French Observatory of non-recourse to rights and services (ODENORE), an expert laboratory in the field of human social sciences and non-recourse to healthcare and services, the Hypoxia and Cardiovascular and Respiratory PhysioPathology (HP2) laboratory (Grenoble, France), with an international reputation for clinical expertise in OSAS and in data analysis, and a local healthcare provider (Agir à Dom—Meylan, France). Patients prescribed and accepting CPAP treatment with telemonitoring will be followed by the home healthcare provider. Patients who refuse CPAP treatment, terminate treatment, or who show poor adherence will be invited to participate in a face-to-face, video, or phone interview with a social sciences researcher from ODENORE. In order to fully address the questions of adherence to CPAP, patients who are adherent are also invited to participate in the aforementioned type of interview.

Participants

Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. Patients who refuse telemonitoring, but accept CPAP treatment, will not be included in the present study. Patients must be affiliated to or be a beneficiary of the French social security or of an equivalent health insurance scheme. Before inclusion in the study, patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes, as well as a written consent form for the recording of any study interviews (see figure 1 for study design and participant flow).

Figure 1.

Study design and participant flow, including the different stages of the study and the information we aim to collect along with potential improvements in CPAP treatment management. CPAP, continuous positive airway pressure.

OSAS is evaluated on the basis of overnight polysomnography performed in a sleep laboratory as per current recommendations.³² If CPAP therapy is prescribed, then at the end of the inclusion visit, the patient is requested to complete a series of online questionnaires.

Patients agreeing to undergo CPAP therapy with telemonitoring are followed up for 6 months through the telemonitoring platform of a home care provider, with home visits by a CPAP technician or nurse at CPAP initiation.

Objective and outcomes

The primary objective is to evaluate the impact of HL level on the refusal, non-adherence, or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The primary outcome is CPAP treatment termination within the first 6 months after CPAP initiation (without continuation of treatment with a mandibular advancement device).

The secondary objectives are summarised in table 1.

Table 1.

Summary of secondary quantitative and qualitative objectives

Quantitative objectives	Qualitative objectives
To evaluate the impact of health literacy levels on CPAP refusal after diagnosis, termination, or non-adherence to treatment in the first 6 months	To decipher the links made by people terminating treatment or non-adherent from a medical point of view, and the various identified factors of non-adherence
To assess the interactions between clinical, socioeconomic, psychological, and home environment factors	To understand how people explain these situations (CPAP termination or non-adherence) based on their life contexts, manifestations of the disease and the treatment, in particular their understanding/misunderstanding(s) of the issues involved
To assess the influence of clinical, socioeconomic, psychological, and home environment factors and 6 month CPAP adherence	To analyse people’s perceptions of their health information practices and their relationship with the medical profession
To determine the profiles of patients who are non-adherent or who have stopped CPAP	To understand the role of healthcare professionals in the processes of the understanding and appropriation of CPAP treatment by the patients
To identify relationship between health literacy and other individual determinants with CPAP adherence trajectories	In CPAP-adherent patients, to explore the relationship between patients and their treatment, and to identify the key factors that lead to successful CPAP adherence
	In patients who terminate CPAP or who are non-adherent, we aim to describe the evolution of their situation and health and describe potential compensation strategies to limit the impact of untreated OSAS. This is achieved by planning a second interview 12 months later, to assess the effect of their decision on various outcomes

CPAP, continuous positive airway pressure; OSAS, obstructive sleep apnoea syndrome.

The secondary quantitative objectives are to evaluate the impact of HL levels on CPAP refusal after diagnosis, termination or non-adherence to treatment in the first 6 months; the interactions between various other clinical, socioeconomic, psychological, and home environment factors and their influence on adherence at 6 months. We also aim to determine the profiles of patients who are non-adherent or who have stopped CPAP due to any of the various determinants collected (financial insecurity, non-take-up of care, living conditions, misunderstanding of treatment, personality traits, etc). inally, this study aims to construct adherence trajectories based on HL and study the influence of other determinants of CPAP adherence.

Secondary qualitative objectives include deciphering the links made by people terminating treatment or non-adherent from a medical point of view, and the various identified factors of non-adherence. We seek to understand how people explain these situations based on their life contexts, manifestations of the disease and the treatment, in particular their understanding/misunderstanding(s) of the issues involved. We intend to analyse people’s perceptions of their health information practices and their relationship with the medical profession, and more particularly with the professionals involved in the management of their respiratory disease, and with regard to the role these professionals play in the processes of the understanding and appropriation of CPAP treatment. To obtain a better understanding of patient non-adherence, we will use semistructured interviews to determine the patient’s knowledge of the pathology, relationship to treatment, relationship to health professionals, and life trajectory in terms of healthcare.

Furthermore, in patients who adhere to CPAP, we aim to explore the relationship between these patients and their CPAP treatment and to identify the key factors that lead them to follow treatment adherence recommendations (ie, fear of medical consequences of OSAS, the role played by peers and/or healthcare professionals, improvement of nocturnal well-being). We will attempt to shed light on what these patients identify as treatment ‘benefits’. A second interview will be carried out with the patients who are adherent to identify the change in their relationship to their treatment and the perceived benefits. In non-adherent patients, this second interview will be aimed at describing the evolution of their situation, the health and potential compensation strategies or alternatives that they have implemented to limit the impact of their untreated OSAS.

To meet these objectives, we will calculate the proportion of refusal of CPAP after diagnosis and the adherent, non-adherent, or treatment termination status at 6 months. Daily CPAP adherence data obtained by telemonitoring will allow us to calculate the mean adherence (over the 6 month period after inclusion). Adherence is defined as a mean CPAP use ≥4 hours versus <4 hours per night for more than 70% of nights.

Study course and measurements

Participants who agree to participate in the study undergo a clinical examination. Medical history, anthropometric data (weight, height, Body Mass Index calculation, neck circumference, abdominal circumference, and hip circumference), and physiological parameters (systolic and diastolic blood pressure, heart rate) are recorded. The patient then completes questionnaires on their level of HL, sociological, and home environment determinants, as well as on their lifestyle and sleep habits (figure 2).

Figure 2.

Summary of data collected in the present study. Anthropometrics, physiological measurements; medical history and treatments. Questionnaires: Bed Partner Sleep Questionnaire; Work–Family Conflict; Mindful Attention Awareness Scale (MAAS); Non-take-up barometer; Short Scale of well-being (SPAN); Deprivation in Primary Care Questionnaire (DipCare-Q); Social Deprivation Score (EPICES); UCLA Loneliness Scale; Energy poverty; Health Literacy (HLS); European Health Literacy Survey Questionnaire (HLS-EU16); Self-efficacy, beliefs, and perceptions about Sleep Apnoea (SEMSA-15); Chronotype (reduced Morning Eveningness Questionnaire (rMEQ)); Physical Activity (Global Physical Activity Questionnaire (GPAQ)); Sleep Questionnaires (Insomnia Severity Index (ISI); Epworth Sleepiness Scale (ESS); Pichot scale for fatigue and depression; Pittsburgh Sleep Quality Index (PSQI)).

HL is assessed using two questionnaires: the European Health Literacy Survey questionnaire (HLS-EU16)³¹ and the Health Literacy Questionnaire (HLS).³³ For the primary outcome measure, the HLS-EU16 will be used (HL is considered insufficient if the score is between 0 and 8, and sufficient if 9 more). HL will also be assessed with the HLQ³³ because this questionnaire provides more detailed information about nine HL dimensions.

The participant then completes the following questionnaires online:

• Deprivation in Primary Care Questionnaire (DipCare-Q).³⁴

• Barometer of non-take-up of Care (BRS)³⁴

• Social deprivation score (EPICES)³⁵

• ODENORE Barometer on energy poverty.³⁴

• Beliefs and perceptions about Sleep Apnoea (SEMSA-15)^{36 37}

• Bed Partner Sleep Questionnaire.³⁸

• Global Physical Activity Questionnaire (GPAQ).³⁹

• Short Scale of well-being (SPANE)^{38 40}

• Mindful Attention Awareness Scale (MAAS).^{41 42}

• UCLA Loneliness Scale⁴³

• Home–Work Conflict.⁴⁴

• Chronotype–rMEQ-SA^{45 46}

• Medical Outcome Study Short Form-36 (SF-36)^{47 48}

• Insomnia Severity Index (ISI).⁴⁹

• Epworth Sleepiness Questionnaire (ESS).⁵⁰

• Pittsburgh Sleep Quality Questionnaire (PSQI).⁵¹

• Pichot fatigue and depression questionnaires.⁵²

The questionnaires are filled in by the patient via a dedicated online account linked to the MARS (Multimorbidity Apnoea Respiratory failure Sleep database) electronic-Case Report Form (e-CRF) of the Grenoble Alpes University Hospital. Data collection is based on the MARS database entry tool. The MARS database is a database designed by the EFCR laboratory at Grenoble Alpes University Hospital. This database has received all the legal authorisations required for its use and scientific exploitation (Advisory Committee on Information Processing in Health Research (CCTIRS) Request No. 15.925bis, approved 23 March 2016; Data Privacy agency (CNIL): Declaration of adherence to reference methodology MR003 No. 1 996 650v0 on 10 May 2016). The database is managed in accordance with General Data Production R rules.

Completing the questionnaires takes approximately 45 min for each participant. They can request the help of a clinical research assistant assigned to the study.

Patients who refuse, terminate, or are non-adherent to CPAP treatment are invited to participate in a semistructured interview conducted by an ODENORE researcher within 15 days of notifying the investigator of CPAP refusal or termination, or within 15 days of the end of the study (for non-adherent patients). This semidirected interview is conducted via a telephone call, a videoconference or face-to-face depending on the patient’s choice. The interview focuses on the links made by people between their refusal and their life context, their ideas about the disease and the treatment, and in particular their understanding/misunderstanding(s). The interviews are structured using a guide prepared by ODENORE researchers together with patient volunteers, in the joint-construction of research tools prioritised by ODENORE. The interview also takes into account the results of the patient’s quantitative data. Each interview lasts between 1 and 2 hours.

Patients who have accepted CPAP treatment with telemonitoring are referred to the home care provider who ensures CPAP installation and monitoring according to standard sleep apnoea monitoring procedures. For these patients, home visits by a CPAP technician or nurse at CPAP initiation are planned. During this initiation visit, the technician or nurse reminds the patient of the physiological mechanism of apnoea–hypopnoea during sleep and the operating principle of CPAP treatment. The type of interface is then chosen, and a trial of the treatment is carried out on awakening for around 15 min, using different pressures. During this trial, the patient learns how to fit the mask, start, and stop the machine, manage leaks, and learn about maintenance and hygiene. One of the aims of the present study is to investigate the pivotal role played by HL on CPAP treatment adherence. Thus, no specific instructions concerning the level of HL are transmitted to the person in charge of installing the CPAP device at the patient’s home. Data on the initial CPAP settings, as well as the type of device and mask are collected and remote monitoring initiated, based on the usual procedures of the home care provider. Over the following 6 months, adherence is collected by telemonitoring. Treatment withdrawal (machine returned and homecare terminated) are recorded by the homecare provider and the investigator is informed. In order to limit any bias’s due to different procedures regarding CPAP initiation, only one homecare provider participated in the present study.

All data are reviewed by the investigator during the 6 month follow-up consultation. Patients who are non-adherent (average adherence less than 4 hours per night over 6 months) or who have stopped CPAP will be offered a semistructured interview, as described above. Participants are classified as CPAP adherent if they use their CPAP more than 4 hours per night for at least 70% of monitored nights.

Figure 1 illustrates the different stages of the study and the information we aim to collect along with potential improvements in CPAP treatment management.

Potential bias

Patients who will refuse CPAP treatment could potentially be those who are more likely to refuse to participate in the study or, if included, refuse to be interviewed, resulting in an unbalanced patient population and missing social data. A register is kept of eligible patients who refuse to participate in the study (date, initials, sex, age, name of investigator and reason if given).

Study size

The sample size for the present study is 250 participants. This sample size was assessed by assuming a 10% CPAP termination rate in the group of participants with acceptable/high HL and a 25% termination rate in the group with low HL. Thus, 200 patients are needed to observe a significant difference between both groups with a power of 0.80 and an alpha risk of 0.05. In order to account for initial refusal and drop-outs, an additional 50 participants will be required.

The inclusion of 14 patients per month is highly feasible as usually 50 patients undergo a polysomnography (PSG) examination in the sleep clinic each month. If necessary, the funding would permit us to extend the inclusion period until December 2024 (2 years). Thus, we plan to include 250 patients who are expected to complete all the study questionnaires at the diagnosis/inclusion visit. Between 30 and 50 of these patients are expected to refuse CPAP treatment (with telemonitoring) or to abandon the treatment before 6 months. Thus, this group of participants will be offered the possibility to participate in the qualitative interviews. We also plan to interview approximately 15 CPAP-adherent patients.

Study status

Patient inclusions started on 1 September 2022 and the first patient was included in October 2022. As of 31 January 2024, 144/250 patients have been included.

Statistical analysis

Descriptive variables

The description of the study population will be done in four steps. First, we will describe all patients, regardless of their adherence status. Second, a description of patients who refused CPAP treatment and a comparison with patients who did not refuse treatment after diagnosis will be carried out. Third, we will describe the patients according to their treatment termination status 6 months after starting treatment and compare those who terminate treatment before 6 months with those with no termination of treatment in the first 6 months. Last, a description of the patients still adhering to treatment at 6 months according to the level of adherence (≥4 hours for at least 70% of nights versus <4 hours mean adherence for more than 70% of nights, adherence quartiles, or trajectory cluster) will be made.

Statistical methods

Comparisons between groups will be made using a χ² test or Fisher’s exact test for qualitative variables and a non-parametric Mann-Whitney test will be used to compare qualitative variables. The analysis of the primary endpoint (risk of refusing CPAP treatment, stopping treatment, or non-adherence) will be carried out using a logistic regression model. A simple linear model will also be used to study the impact of HL on CPAP adherence by considering adherence as a continuous variable for patients still on treatment at 6 months. For both models, variable selection method will be based on expert knowledge and assessment for variable collinearity. The variables (including HL) most associated with terminating treatment or CPAP adherence will be introduced in a multivariate model. To study the interaction between the different determinants modulating CPAP adherence, an approach based on structural equation models will be used. This will make it possible to identify the direct and indirect relationships of the various determinants collected in the questionnaires. An extension of this approach could make it possible to identify, for each questionnaire, which items would be most relevant to study the impact on adherence. An unsupervised classification method (clustering) will also be used to: (1) identify profiles of patients who are non-adherent or who have stopped CPAP in relation to the various determinants collected and (2) identify patient adherence trajectories.

Patient and public involvement

Volunteer patients have collaborated with social scientists in the design of the research tools developed by ODENORE in the past. The interviews that will be carried out with participants who refuse CPAP treatment with telemonitoring and/or who terminate CPAP treatment have an open format allowing interviewees to freely express their opinions about CPAP treatment and adherence issues. The study team welcomes ideas from patients who could suggest issues that might not have been previously investigated.

Ethics and dissemination

Ethics approval

The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). Notification of the Committee’s approval was forwarded to the National Medicines Safety Agency (ANSM) by the sponsor (Grenoble Alpes University Hospital, Delegation for Clinical Research and Innovation). Participants are required to have signed a written consent form.

Dissemination of findings

A key output of this project will be the development of tools and training programmes for healthcare professionals and CPAP homecare providers to improve the care of patients with OSAS based on the results of this study and by including patients’ points of views. Furthermore, we aim to determine sociomarkers based on key aspects that are raised by patients and to identify questionnaires that best evaluate HL at the time of diagnosis (figure 3).

Figure 3.

A transdisciplinary approach aimed at reducing CPAP treatment refusal and termination: from the identification of patient profiles to the optimisation of treatment. CPAP adherent: CPAP use >4 hours per night for at least 70% of monitored nights. CPAP, continuous positive airway pressure; OSAS, obstructive sleep apnoea syndrome.

Dissemination plans include presentations of the results at medical and social science national and international conferences and publication in a peer-reviewed journal. We will also publish the results on institution websites.

Discussion

This study aims to contribute to the optimisation of the management of people suffering from sleep apnoea, by establishing a personalised medicine-oriented care pathway. A better understanding of the impact of HL as well as the identification of other potential non-clinical determinants influencing adherence collected at the time of OSAS diagnosis should contribute to personalising the management and care of patients, from its very beginning. It will also be useful when explaining OSAS and CPAP treatments to patients, at the initiation of the treatment, and throughout their care.

The major strength of this study is its transdisciplinary approach which is facilitated by a longstanding collaboration between a large university hospital sleep clinic, social scientists, and a CPAP homecare provider. This collaboration allows us to consider all aspects influencing CPAP refusal, termination, or poor adherence to treatment. The present study has limitations such as recruitment bias; notably, patients who decide not to participate in the study may be those who are more likely to refuse CPAP treatment or who have lower HL.⁵³ Another limitation is ‘questionnaire fatigue’ that affects both the patients and the clinical research assistants. During the inclusion visit, patients are asked to complete a large number of questionnaires and the estimated time to complete them is 45 min. While in this study there are no modifications made to already validated questionnaires, the present study will allow us to select the most relevant items from the different quantitative questionnaires and incorporate them into a single new CPAP-specific questionnaire which will be much shorter to complete and will be tested and validated in future studies. In addition, despite help from a clinical research assistant, patients with poor French or poor reading skills may have difficulties in completing all the questionnaires.

An alternative or additional approach might have been to use the SDOH data collected by the National Institute for Social and Economic Studies (INSEE) in their censuses. However, some of this SDOH data depend on the INSEE geocode of the district (or zone) where the patient lives and thus is not completely individualised.

Conducting individual interviews makes it possible to take into account the opinions of patients and to provide a learning experience for the professionals involved in their care. Giving patients a voice will allow both patients and physicians to understand the meaning patients attribute to so-called non-adherence situations. Furthermore, it will allow the optimisation of the information provided by health professionals and their way of explaining treatments to the individual patient, further taking into account the most essential elements. The analysis of the quantitative data associated with the elements collected through the qualitative interviews, in particular those concerning the obstacles raised by the patients to treatment adherence, will constitute a point of support for proposing recommendations for individualised care at the time of diagnosis and also over the whole course of the patients’ treatment. The comparative analysis of interviews in adherent and non-adherent patients will allow further understanding of the impact of a number of different factors, such as social factors, on the relationship between patients and their OSAS treatment. Finally, this approach based on OSAS is a demonstration of what could be done for other chronic diseases requiring long-term care and involving a similar type of device.

Ethics statements

Patient consent for publication

Not applicable.