Sleep apnea Nervous System Diseases
Conditions
Interventions
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 p
Sponsors
Directorate-General for Research and Innovation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria: 1. Any ongoing treatment for OSA or central sleep apnea (CSA) 2. Known significant hypercapnic respiratory failure due to chronic obstructive pulmonary disease or other respiratory condition 3. Any other clinically determined contraindication for PAP treatment 4. Patients participating in any type of weight loss treatment program 5. Unstable congestive heart failure or angina pectoris 6. Any other condition – to the judgement of the investigator – which potentially may jeopardize the completion of the study according to protocol 7. History of alcohol or drug abuse during the last year, substance use disorder at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Romania, Sweden, Türkiye
Outcome results
None listed