Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
The goal of this observational study is to evaluate a new classification system for obstructive sleep apnoea in patients with newly diagnosed obstructive sleep apnoea and monitor for long-term objective and subjective improvement.
Interventions
None listed
Sponsors
Wissenschaftliches Institut Bethanien e.V
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patient ≥40 years at the time of signed informed consent 2. Diagnosis of predominant obstructive sleep apnoea with a total apnoea-hypopnoea index of ≥5 /h based on a diagnostic sleep study (polysomnography or polygraphy, as per local standard). Predominant obstructive sleep apnoea defined as ≥70% of respiratory events classified as obstructive. 3. Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations
Exclusion criteria
1. \>30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study 2. Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy) 3. Use, or need for chronic use, of any non-invasive positive pressure ventilation device 4. Participation in an interventional study and/or receiving investigational treatment(s) 5. Significant disease or condition, which, in the opinion of the investigator, may interfere with study procedures or cause concern regarding the patient's ability to participate in the study 6. Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daytime sleepiness as measured by the Epworth Sleepiness Scale | From enrollment to the end of the individual observation period at 36 months | The Epworth Sleepiness Scale total score ranges from 0-24. Higher values represent a larger extent of daytime sleepiness |
| Change in office systolic blood pressure | From enrollment to the end of the individual observation period at 36 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average OSA treatment usage | From enrollment to the end of the individual observation period at 36 months | Average usage of the prescribed treatment for obstructive sleep apnea, measured as hours per day, derived from therapy device data |
| Number of patients who discontinue OSA treatment | From enrollment to the end of the individual observation period at 36 months | — |
| Change in Insomnia Severity Index total score | From enrollment to the end of the individual observation period at 36 months | The Insomnia Severity Index (ISI) total score ranges from 0-28. Higher scores represent a larger extent of insomnia-related symptoms. Scores of 15 and above are indicative of clinical insomnia. |
| Change in office diastolic blood pressure | From enrollment to the end of the individual observation period at 36 months | — |
| Change in Fatigue Severity Scale mean score | From enrollment to the end of the individual observation period at 36 months | The Fatigue Severity Scale (FSS) mean score ranges from 0-7, with higher values indicating a larger extent of fatigue. |
| Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score | From enrollment to the end of the individual observation period at 36 months | The Montreal Cognitive Assessment (MoCA) total score ranges from 0-30. A higher score represents a better cognitive performance. A result of 26 or higher is considered normal. |
| Change in average oxygen desaturation area as measured by overnight oximetry | From enrollment to the end of the individual observation period at 36 months | The average oxygen desaturation area (unit: s\*%) is automatically calculated from the oximetry signal of a single night poly(somno)graphy. Higher values indicate a larger extent of hypoxic burden. |
| Change in subjective sleep length | From enrollment to the end of the individual observation period at 36 months | Subjective sleep length as assessed via personal interview, measured in hours per night |
| Cardiovascular events (MACE) occurring after study inclusion, including but not limited to myocardial infarction, stroke, hospitalisation for cardiovascular-related treatment (e.g. heart failure, arrhythmia) | From enrollment to the end of the individual observation period at 36 months | — |
Countries
Belgium, France, Germany, Greece, Italy, Poland, Portugal, Romania, Slovenia, Switzerland, Turkey (Türkiye)
Contacts
Primary ContactMarcel Treml, Dr.
Outcome results
None listed