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NCT Number: NCT06861686

A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient ≥40 years at the time of signed informed consent
  • 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.
  • Signed and dated written informed consent in accordance with ICH-GCP and applicable local regulations

Exclusion criteria

  • >30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study
  • Established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy)
  • Use, or need for chronic use, of any non-invasive positive pressure ventilation device
  • Participation in an interventional study and/or receiving investigational treatment(s)
  • 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
  • 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)

Treatment and study plan

Primary outcomes

  1. Change in daytime sleepiness as measured by the Epworth Sleepiness Scale

    Time frame: 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

  2. Change in office systolic blood pressure

    Time frame: From enrollment to the end of the individual observation period at 36 months

Secondary outcomes

  1. Change in office diastolic blood pressure

    Time frame: From enrollment to the end of the individual observation period at 36 months

  2. 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)

    Time frame: From enrollment to the end of the individual observation period at 36 months

  3. Average OSA treatment usage

    Time frame: 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

  4. Number of patients who discontinue OSA treatment

    Time frame: From enrollment to the end of the individual observation period at 36 months

  5. Change in Insomnia Severity Index total score

    Time frame: 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.

  6. Change in subjective sleep length

    Time frame: 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

  7. Change in Fatigue Severity Scale mean score

    Time frame: 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.

  8. Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score

    Time frame: 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.

  9. Change in average oxygen desaturation area as measured by overnight oximetry

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcel Treml, Dr.

CONTACT

[email protected]

+49212636661

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Registry information

Official study title

A Modified Baveno Classification of Obstructive Sleep Apnoea Based on Sleepiness and Cardiovascular Scores: A Prospective Observational Cohort Study

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 6, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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