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Sleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure (BIOSA)

26 sierpnia 2026 zaktualizowane przez: Bughin Francois, Clinique du Millenaire

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

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

200

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
      • Montpellier, Francja, 34000
        • Rekrutacyjny
        • Clinique Millenaire
        • Kontakt:
          • Francois FB Bughin, Study Principal Investigator
          • Numer telefonu: 0033761783081
          • E-mail: fbughin@hotmail.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Patients with newly diagnosed obstructive sleep apnea
Adults with newly diagnosed obstructive sleep apnea and a clinical indication for continuous positive airway pressure therapy. Treatment is prescribed according to routine clinical practice. Participants are followed for three months to evaluate treatment adherence, symptoms, quality of life, and sleep apnea biomarkers.
Urządzenie: Continuous Positive Airway Pressure
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.
Inne nazwy:
  • CPAP
  • Dodatnie ciśnienie w drogach oddechowych

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Association Between Baseline Hypoxic Burden and CPAP Adherence at 3 Months
Ramy czasowe: 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.
Baseline to 3 months after CPAP initiation

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Distribution of Baseline Sleep Apnea Biomarkers
Ramy czasowe: 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.
BASELINE
Association Between Baseline Heart Rate Response and CPAP Adherence at 3 Months
Ramy czasowe: 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.
Baseline to 3 months after CPAP initiation
Association Between Baseline Pulse Wave Amplitude Drop Index and CPAP Adherence at 3 Months
Ramy czasowe: 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.
Baseline to 3 months after CPAP initiation
Daytime Sleepiness Assessed by the Epworth Sleepiness Scale
Ramy czasowe: 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.
Baseline and 3 months
Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire
Ramy czasowe: 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.
baseline and 3 months
Goal Attainment Assessed by Goal Attainment Scaling
Ramy czasowe: 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
baseline and 3 months
Change in Sleep Apnea-Specific Hypoxic Burden During CPAP Therapy
Ramy czasowe: 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.
baseline and 3 months
Change in Pulse Wave Amplitude Drop Index During CPAP Therapy
Ramy czasowe: 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.
Baseline and 3 months after CPAP initiation
Change in Heart Rate Response to Respiratory Events During CPAP Therapy
Ramy czasowe: 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.
Baseline and 3 months after CPAP initiation

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Clinique du Millenaire

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 lutego 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2026

Ukończenie studiów (Szacowany)

30 września 2027

Daty rejestracji na studia

Pierwszy przesłany

10 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

28 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BIOSA
  • 2025-A01061-48 (Inny identyfikator: French National Agency for the Safety of Medicines and Health Products (ANSM))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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