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NCT Number: NCT07792746

Sleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure

Obstructive sleep apnea (OSA) is commonly assessed using the apnea-hypopnea index, although this measure does not fully reflect cardiovascular risk or the physiological impact of the disease. Emerging biomarkers, including sleep apnea-specific hypoxic burden, pulse wave amplitude drop index, and heart rate response, may provide additional information on cardiovascular vulnerability.

This prospective multicenter observational study will investigate the association between these biomarkers, measured from the diagnostic sleep study, and adherence to continuous positive airway pressure (CPAP) therapy after three months. Symptoms, quality of life, clinical characteristics, and changes in biomarkers under continuous positive airway pressure will also be evaluated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Millenaire

Montpellier, 34000, France

Location status: Recruiting

Location contact

Francois FB Bughin, Study Principal Investigator

CONTACT

[email protected]

0033761783081

About this study

This is a prospective, longitudinal, multicenter observational cohort study involving adults with newly diagnosed obstructive sleep apnea for whom continuous positive airway pressure therapy is indicated as part of routine clinical care.

At baseline, demographic and clinical characteristics, medical history, current treatments, symptom questionnaires, and results from diagnostic respiratory polygraphy or polysomnography will be collected. Hypoxic burden, pulse wave amplitude drop index, and heart rate response will be calculated from the initial sleep recording. Continuous positive airway pressure will be prescribed according to standard clinical practice.

At 12 weeks, with a permitted window of plus or minus four weeks, adherence data will be obtained from the continuous positive airway pressure device. Clinical information and questionnaires will be collected again. Participants requiring a follow-up sleep study as part of routine care may undergo respiratory polygraphy or polysomnography while receiving continuous positive airway pressure, allowing assessment of biomarker changes under treatment.

The principal analysis will examine associations between baseline biomarkers and continuous positive airway pressure adherence. Secondary analyses will assess biomarker distributions according to clinical characteristics, associations with symptoms and quality of life, and changes in biomarkers during treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed obstructive sleep apnea with an indication for continuous positive airway pressure therapy
  • Age older than 18 years
  • Written informed consent obtained

Exclusion criteria

  • Continuous positive airway pressure treatment during the preceding 3 months
  • Medical contraindication to continuous positive airway pressure therapy
  • Concomitant condition likely to affect adherence to continuous positive airway pressure, including severe cognitive impairment or an unstable psychiatric disorder

Treatment and study plan

Continuous Positive Airway Pressure

Device

Continuous positive airway pressure prescribed as part of routine clinical care according to applicable clinical recommendations. The study does not assign the treatment or its settings.

Other names: CPAP, Positive Airway Pressure

Primary outcomes

  1. Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months

    Time frame: Baseline to 3 months after CPAP initiation

    Association between hypoxic burden measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night.

Secondary outcomes

  1. Distribution of Baseline Sleep Apnea Biomarkers

    Time frame: BASELINE

    Distribution of hypoxic burden, pulse wave amplitude drop index, and heart rate response measured or calculated from the baseline respiratory polygraphy or polysomnography. Results will be described according to sex, age, body mass index, medical history, cardiovascular history, and current treatments.

  2. Association Between Baseline Heart Rate Response and CPAP Adherence at 3 Months

    Time frame: Baseline to 3 months after CPAP initiation

    Association between the heart rate response to respiratory events (delta heart rate) measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night.

  3. Association Between Baseline Pulse Wave Amplitude Drop Index and CPAP Adherence at 3 Months

    Time frame: Baseline to 3 months after CPAP initiation

    Association between the pulse wave amplitude drop index (PWAD index) measured during the baseline diagnostic sleep study and mean nightly CPAP use during the 30 days preceding the 3-month visit. CPAP adherence will also be categorized as less than 4 hours per night versus 4 hours or more per night.

  4. Daytime Sleepiness Assessed by the Epworth Sleepiness Scale

    Time frame: Baseline and 3 months

    Daytime sleepiness will be assessed using the Epworth Sleepiness Scale at baseline and 3 months after CPAP initiation. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness and therefore a worse outcome. The change in total score between baseline and 3 months will be evaluated.

  5. Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire

    Time frame: baseline and 3 months

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and 3 months after CPAP initiation. The EQ-5D-5L evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from 1 (no problems) to 5 (extreme problems or inability to perform the activity). Responses will be converted into an EQ-5D-5L utility index using the French value set. Index values range from -0.525 to 1, with higher values indicating better health-related quality of life. The change in the utility index between baseline and 3 months will be evaluated.

  6. Goal Attainment Assessed by Goal Attainment Scaling

    Time frame: baseline and 3 months

    Goal Attainment Scaling score and its change between baseline and the 3-month follow-up visit. Attainment of the participant's individualized treatment goal will be assessed at 3 months using Goal Attainment Scaling (GAS). Goal attainment is rated on a five-point scale ranging from -2 to +2: -2 indicates a much worse outcome than expected, -1 a somewhat worse outcome than expected, 0 the expected level of goal attainment, +1 a somewhat better outcome than expected, and +2 a much better outcome than expected. Higher scores indicate better goal attainment and therefore a better outcome

  7. Change in Sleep Apnea-Specific Hypoxic Burden During CPAP Therapy

    Time frame: baseline and 3 months

    Sleep apnea-specific hypoxic burden will be calculated from the oxygen desaturation area associated with respiratory events and expressed as percent-minutes per hour (%min/h). The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate a greater hypoxic burden and therefore a worse outcome. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care.

  8. Change in Pulse Wave Amplitude Drop Index During CPAP Therapy

    Time frame: Baseline and 3 months after CPAP initiation

    The pulse wave amplitude drop index will be calculated as the number of pulse wave amplitude drops per hour of sleep or recording. The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate more frequent pulse wave amplitude drops. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care.

  9. Change in Heart Rate Response to Respiratory Events During CPAP Therapy

    Time frame: Baseline and 3 months after CPAP initiation

    Heart rate response will be measured as the mean change in heart rate associated with respiratory events (delta heart rate). The change from the baseline diagnostic sleep study to the sleep study performed during CPAP therapy at 3 months will be evaluated. Higher values indicate a greater heart rate response to respiratory events. This assessment will be performed only in participants undergoing a follow-up sleep study as part of routine care.

Study contacts

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

Francois FB Bughin, MD, PhD

CONTACT

[email protected]

0033761783081

Sponsors and collaborators

Lead sponsor

Clinique du Millenaire

Other

Registry information

Official study title

Impact of Obstructive Sleep Apnea Biomarkers on Adherence to Continuous Positive Airway Pressure: Role of Pulse Wave Amplitude Drop Index, Hypoxic Burden, and Heart Rate Variability

Acronym: BIOSA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

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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