Sleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClinique du Millenaire
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed obstructive sleep apnea with an indication for continuous positive airway pressure therapy
Age older than 18 years
Written informed consent obtained
Disqualifiers
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
Trial population
Adults with newly diagnosed obstructive sleep apnea syndrome and an indication for continuous positive airway pressure therapy, recruited from approximately 10 sleep medicine centers in France. Participants are treated according to routine clinical practice and followed for 3 months to assess CPAP adherence, symptoms, quality of life, and sleep apnea biomarkers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Continuous Positive Airway Pressure
DeviceContinuous 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients with newly diagnosed obstructive sleep apnea1 intervention
Trial outcomes
Primary outcomes
1
Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
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.
Time frame
Baseline to 3 months after CPAP initiationSecondary outcomes
1
Distribution of Baseline Sleep Apnea Biomarkers
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.
Time frame
BASELINE2
Association Between Baseline Heart Rate Response and CPAP Adherence at 3 Months
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.
Time frame
Baseline to 3 months after CPAP initiation3
Association Between Baseline Pulse Wave Amplitude Drop Index and CPAP Adherence at 3 Months
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.
Time frame
Baseline to 3 months after CPAP initiation4
Daytime Sleepiness Assessed by the Epworth Sleepiness Scale
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.
Time frame
Baseline and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov