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Study identifier: NCT06578390 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis

Condition: Sleep Apnea Syndromes  ·  Sponsor: Mitral

PhaseNA
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care. The main questions it aims to answer are: * Can Apneal® accurately classify the SAS severity into four categories (normal: AHI \< 5, mild: 5 ≤ AHI \< 15, moderate: 15 ≤ AHI \< 30, and severe: AHI ≥ 30) compared to PSG ? * How does Apneal® perform in estimating the Apnea-Hypopnea Index (AHI), detecting sleep stages, differentiating between central and obstructive apneas, and identifying patient movements? Participants will: * Wear the Apneal® app-equipped smartphone and undergo PSG during a full night of sleep at home. * Complete several questionnaires assessing sleep symptoms and experience with the Apneal® app.

This description comes directly from the study's public registry record.

Talk to the study team

Guillaume Cathelain, PhD  ·  +33672448711  ·  guillaume.cathelain@apneal.ai

Lola Martin  ·  +33744475942  ·  lola.martin@stane-groupe.fr

Always discuss trial participation with your own doctor first.

Locations (11)

Centre de pneumologie et sommeilAix-en-Provence, FranceRecruiting
Centre du sommeil d'AntonyAntony, FranceRecruiting
Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-AirBordeaux, FranceRecruiting
SomnoLab - MillénaireMontpellier, FranceNot Yet Recruiting
Cabinet de médecine du sommeil - CabsomMulhouse, FranceRecruiting
SomnologyParis, FranceRecruiting
Institut médical du sommeilParis, FranceNot Yet Recruiting
Cabinet privé du Dr. WanonoReims, FranceRecruiting
Clinique du RenaisonRoanne, FranceRecruiting
SomnidocRoanne, FranceRecruiting
Centre ClinicalSoyaux, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06578390