Sleep Revolution - evaluation of a novel diagnostic and therapeutic pathway for patients with obstructive sleep apnea

INTERVENTION: Study SR‐001 is a multi‐center, two‐arm, cross‐over study comparing the diagnostic impact and accuracy of two different diagnostic pathways on the outcome of diagnosis and continuous positive airway pressure (CPAP) treatment in patients with suspected obstructive sleep apnea (OSA). Patients referred to one of 24 sleep centers of the Escuela Superior de Arte y Diseño de Andalucía (ESADA) network participating in the Sleep Revolution project will be studied using both the clinical routine of OSA evaluation (standard care [SC]) and the novel Sleep Revolution‐based diagnostic pathway including self‐applied polysomnography over 3 nights, digitally based symptom evaluation, and actigraphy‐based assessment of sleep‐wake rhythm and physical activity (experimental condition). Randomisation is carried out in blocks of four patients, and a randomisation list will be distributed to each participating centre in the study. The randomisation list was generated by a publicly available service at https://www.sealedenvelope.com/simple‐randomiser/v1/lists on 17 August 2023 with the seed for the randomization list of 275031337567920. Actual randomization will be performed at each study site by personnel otherwise not involved in the study. Standard sleep diagnostic procedure (standard care pathway): Single night polygraphy or polysomnography both at baseline. Limited numbers of questionnaire data. The experimental setting (Sleep Revolution pathway) includes three nights of self‐applied polysomnography, app‐based assessment of symptoms, sleep diary, cognitive function and physical activity. Actigraphy‐based assessment of sleep‐wake cycle and objective physical activity. In case of clinically relevant sleep apnea according to the results of the diagnostic assessment, patients will be off CONDITION: Sleep apnea ; Nervous System Diseases PRIMARY OUTCOME: Staff time spent for the sleep apnea diagnostic pathway – comparison between Standard Care (SC) and the Sleep Revolution (SR) model in patients with suspected obstructive sleep apnea (OSA) from patient inclusion to final consultation with the sleep physician (units: minutes) INCLUSION CRITERIA: Main INCLUSION CRITERIA: 1. Referral to the sleep center due to suspected obstructive sleep apnea as the main question for evaluation 2. Male or female aged 18 years and above 3. Willing and able to provide written informed consent 4. Willing and able to comply with the study design schedule and other requirements (e.g. no long‐term travel conflicting with the planned visits throughout the study) SECONDARY OUTCOME: 1. Patient satisfaction and preference with the diagnostic work‐up (score of the patient global impression scale and the patient preference question) at visit 1c: end of diagnostic procedure; 2. Patient satisfaction with the resolution of the initial help request through diagnosis and treatment (only in patients with CPAP therapy, specific question in the European Sleep Questionnaire) at V3b: end of study follow‐up visit; 3. Number of OSA diagnoses, Positive Airway Pressure (PAP) treatment prescriptions, and non‐PAP prescriptions by either pathway (number of patients in each group) at V1c and V3b; 4. Number of patients with PAP failure (no acceptance/low adherence) by either pathway (number of patients in each group) at V3b; 5. Prediction of PAP treatment responders in terms of adherence and symptom improvement by novel diagnostic parameters (SR versus SC) (predictor analysis of adherence with PAP treatment in h/night, conventional diagnostic markers versus novel diagnostic markers) at V3b; 6. Association between sleep test output variables (polysomnography [PSG] and home sleep apnea test [HSAT]) (respiration, hypoxia, cardiovascular function, sleep) and symptoms/comorbidities obtained in SC and SR at V1c