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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients will wear the device during their polysomnographic recording |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apneal device | Device | Patients will wear a smartphone with the Apneal Application on their chest, while they perform polysomnography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS) | Performance of Apneal® in classifying the severity of SAHS into four categories (normal: AHI < 5, mild: 5 ≤ AHI < 15, moderate: 15 ≤ AHI < 30, severe: AHI ≥ 30) compared to polysomnography (PSG). | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the Apnea-Hypopnea Index (AHI) using Apneal® | Concordance of AHI measured by Apneal® with AHI measured by PSG, and the mean absolute error between the two measurements. | through study completion, an average of 1 year |
| Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Cathelain, PhD | Contact | +33672448711 | guillaume.cathelain@apneal.ai | |
| Lola Martin | Contact | +33744475942 | lola.martin@stane-groupe.fr |
| Name | Affiliation | Role |
|---|---|---|
| Ruben Wanono, MD | CHU de Reims | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de pneumologie et sommeil | Recruiting | Aix-en-Provence | 13290 | France |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Each patient will wear the device and polysomnograph at the same time
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Comparison of Apneal®'s performance with the NoSAS, Berlin, and Epworth questionnaires in classifying the severity of SAHS into the four categories (normal, mild, moderate, severe) relative to PSG. |
| through study completion, an average of 1 year |
| Detect sleep stages using Apneal® | The minimum concordance between Apneal® and PSG for both sleep stage durations (wake, REM, NREM: N1, N2, N3) and sleep stage latencies. | through study completion, an average of 1 year |
| Differentiate central and obstructive apneas using Apneal® | Estimation of the Central Apnea Index (CAI) by Apneal® compared to PSG, indicating the number of central apneas per hour of sleep. | through study completion, an average of 1 year |
| Detect patient movements with Apneal® | Comparison of night segmentation by movements (presence/absence) between Apneal® and PSG, and evaluation of the number of movements detected by both. | through study completion, an average of 1 year |
| Evaluate patient acceptability of Apneal® | Percentage of patients who agree to participate vs. those who refuse, including reasons for refusal (e.g., equipment-related issues, cognitive impairment). | through study completion, an average of 1 year |
| Assess the feasibility of SAHS screening using Apneal® | Percentage of patients with usable data provided by Apneal® out of the total number of patients included; data considered unusable if Apneal® is lost during the night. | through study completion, an average of 1 year |
| Centre du sommeil d'Antony | Recruiting | Antony | 92160 | France |
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| Pôle d'Exploration des Apnées du Sommeil de la Nouvelle Clinique Bel-Air | Recruiting | Bordeaux | 33200 | France |
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| SomnoLab - Millénaire | Not yet recruiting | Montpellier | 34000 | France |
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| Cabinet de médecine du sommeil - Cabsom | Recruiting | Mulhouse | 68200 | France |
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| Somnology | Recruiting | Paris | 75015 | France |
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| Institut médical du sommeil | Not yet recruiting | Paris | 75116 | France |
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| Cabinet privé du Dr. Wanono | Recruiting | Reims | 51100 | France |
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| Clinique du Renaison | Recruiting | Roanne | 42300 | France |
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| Somnidoc | Recruiting | Roanne | 42300 | France |
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| Centre Clinical | Not yet recruiting | Soyaux | 16800 | France |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |