Obstructive sleep apnea, sleep apnea Obstructive sleep apnea, sleep apnea
Conditions
Interventions
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Clinically relevant symptoms, at physician's discretion. o Reduced emotional wellbeing • High OSA risk based on STOP-BANG questionnaire • >=18 years old • In possession of a Smartphone running on a recent version of iOS or Android • Proficient in the Dutch language, enabling them to understand and complete questionnaires without assistance.
Exclusion criteria
Exclusion criteria: • (Night) shift workers • 4 or more alcoholic drinks per day on a regular basis or use of recreational drugs Following conditions might not return reliable digital OSA data, as the Withings Sleep Analyzer algorithm is not trained or tested in these contexts. Therefore (suspicion) of below conditions are listed as exclusion criteria: • Presence of acute or severe chronic respiratory muscle weakness due to neuromuscular condition • Awake hypoventilation • Suspicion of sleep-related hypoventilation • Chronic opiod medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints Digital health metrics and EMA items The quantitative assessment will statistically explore the relationship between digital OSA-related health metrics that are continuously collected using sensor-based digital health technologies with subjective data that is collected via a short EMA questionnaire that is administered each morning . As such, the subjective morning EMA data can be seen as the study*s primary endpoint, whereas the objective nocturnal digital health data are the key study parameters of interest that may be related to the subjective data. Exit survey and interviews Study participants will fill out a survey about meaningfulness of assessed digital health parameters based on the personal health data report that they receive at the end of study (survey is included as attachment). Additionally, a representative sample of participants is invited for a semi-structured interview to establish meaningfulness and actionability of each health parameter in the patient data report, that they receive after the final night of measurements (interview guide is included as attachment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints PROM The Quebec Sleep Questionnaire (QSQ) is a 32-item scale that evaluates the impact of OSA over the past 4 weeks in five different domains, namely hypersomnolence, daytime symptoms, nighttime symptoms, emotions, and social interaction. The QSQ will be taken at study onset, at the start of the patient*s treatment and 1 and 2 months after treatment initiation. These data will be used to at least (1) describe the patient sample to aid the interpretation of the generalizability of the current study using T0 QSQ data, as well as potentially (2) describe the patients* complaints in the descriptive secondary endpoint, (3) help predict the PG-related OSA diagnosis outcomes in the related secondary objective using T0 QSQ data, and (4) explore to what degree the trends in the daily EMA items and/or daily OSA-related digital health metrics relate to QSQ outcomes. | — |
Countries
Netherlands
Contacts
Public ContactN.L. Haring
TNO
Outcome results
None listed