NCT07792746

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2026Sep 2027

Study Start

First participant enrolled

February 18, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 10, 2026

Last Update Submit

August 26, 2026

Conditions

Obstructive Sleep Apnea (OSA)CPAPBiomarkers for Prediction of OA Treatment Efficacy

Keywords

Obstructive sleep apneaSleep apnea syndromeContinuous positive airway pressurecpap adherenceHypoxic burdenPulse wave amplitude drop indexpwadHeart rate responseSympathetic nervous system

Outcome Measures

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.

    Baseline to 3 months after CPAP initiation

Secondary Outcomes (9)

  • Distribution of Baseline Sleep Apnea Biomarkers

    BASELINE

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

    Baseline to 3 months after CPAP initiation

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

    Baseline to 3 months after CPAP initiation

  • Daytime Sleepiness Assessed by the Epworth Sleepiness Scale

    Baseline and 3 months

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

    baseline and 3 months

  • +4 more secondary outcomes

Study Arms (1)

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.

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway PressureDEVICE

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.

Also known as: CPAP, Positive Airway Pressure
Patients with newly diagnosed obstructive sleep apnea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Millenaire

Montpellier, 34000, France

RECRUITING

Related Publications (7)

  • Gagnadoux F, Bequignon E, Prigent A, Micoulaud-Franchi JA, Chambe J, Texereau J, Alami S, Roche F. The PAP-RES algorithm: Defining who, why and how to use positive airway pressure therapy for OSA. Sleep Med Rev. 2024 Jun;75:101932. doi: 10.1016/j.smrv.2024.101932. Epub 2024 Apr 8.

    PMID: 38608395RESULT

  • Pinilla L, Esmaeili N, Labarca G, Martinez-Garcia MA, Torres G, Gracia-Lavedan E, Minguez O, Martinez D, Abad J, Masdeu MJ, Mediano O, Munoz C, Cabriada V, Duran-Cantolla J, Mayos M, Coloma R, Montserrat JM, de la Pena M, Hu WH, Messineo L, Sehhati M, Wellman A, Redline S, Sands S, Barbe F, Sanchez-de-la-Torre M, Azarbarzin A. Hypoxic burden to guide CPAP treatment allocation in patients with obstructive sleep apnoea: a post hoc study of the ISAACC trial. Eur Respir J. 2023 Dec 7;62(6):2300828. doi: 10.1183/13993003.00828-2023. Print 2023 Dec.

    PMID: 37734857RESULT

  • Gerves-Pinquie C, Bailly S, Goupil F, Pigeanne T, Launois S, Leclair-Visonneau L, Masson P, Bizieux-Thaminy A, Blanchard M, Sabil A, Jaffuel D, Racineux JL, Trzepizur W, Gagnadoux F. Positive Airway Pressure Adherence, Mortality, and Cardiovascular Events in Patients with Sleep Apnea. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1393-1404. doi: 10.1164/rccm.202202-0366OC.

    PMID: 35816570RESULT

  • McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

    PMID: 27571048RESULT

  • Azarbarzin A, Sands SA, Younes M, Taranto-Montemurro L, Sofer T, Vena D, Alex RM, Kim SW, Gottlieb DJ, White DP, Redline S, Wellman A. The Sleep Apnea-Specific Pulse-Rate Response Predicts Cardiovascular Morbidity and Mortality. Am J Respir Crit Care Med. 2021 Jun 15;203(12):1546-1555. doi: 10.1164/rccm.202010-3900OC.

    PMID: 33406013RESULT

  • Solelhac G, Sanchez-de-la-Torre M, Blanchard M, Berger M, Hirotsu C, Imler T, Sanchez-de-la-Torre A, Haba-Rubio J, Marchi NA, Bayon V, Bailly S, Goupil F, Waeber A, Heiniger G, Pigeanne T, Gracia-Lavedan E, Zapater A, Abad J, Ordax E, Masdeu MJ, Cabriada-Nuno V, Egea C, Van Den Broecke S, Vollenweider P, Marques-Vidal P, Vaucher J, Bernardi G, Betta M, Siclari F, Barbe F, Gagnadoux F, Heinzer R. Pulse Wave Amplitude Drops Index: A Biomarker of Cardiovascular Risk in Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2023 Jun 15;207(12):1620-1632. doi: 10.1164/rccm.202206-1223OC.

    PMID: 37017487RESULT

  • Azarbarzin A, Sands SA, Stone KL, Taranto-Montemurro L, Messineo L, Terrill PI, Ancoli-Israel S, Ensrud K, Purcell S, White DP, Redline S, Wellman A. The hypoxic burden of sleep apnoea predicts cardiovascular disease-related mortality: the Osteoporotic Fractures in Men Study and the Sleep Heart Health Study. Eur Heart J. 2019 Apr 7;40(14):1149-1157. doi: 10.1093/eurheartj/ehy624.

    PMID: 30376054RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Central Study Contacts

Francois FB Bughin, MD, PhD

CONTACT

0033761783081fbughin@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 28, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations

FR(1)