NCT06896448

Innovative OSA Screening in Head and Neck Cancer Patients With the Apneal App

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Obstructive sleep apnea syndrome is a common but often underdiagnosed condition, with significant impacts on quality of life, such as fatigue, attention disorders, and an increased risk of heart attack or stroke. Structural changes in the head and neck region appear to contribute to the onset or worsening of this condition. To improve patients' quality of life, early diagnosis is essential. Currently, diagnosis relies on expensive devices, often associated with long waiting times. To address these challenges, an innovative solution is proposed: a smartphone application enabling a simple and accessible diagnosis. This application is currently under validation and has not yet been commercialized. The purpose of the study is to determine whether this smartphone application can be used in clinical practice for patients with a head and neck lesion to diagnose sleep apnea syndrome and to assess its progression during the medical care. This study is for patients who present a head and neck lesion currently under evaluation in our department at Caen University Hospital. This research will be integrated into routine follow-up for a period of six months. The medical device used in this study, Apneal, is a smartphone application currently undergoing validation for the rapid diagnosis of sleep apnea syndrome. Its use is simple: the smartphone is placed in airplane mode and secured to the chest overnight. Using the phone's built-in sensors, respiratory sleep data is collected and analyzed. As part of the initial assessment, a dedicated sleep consultation is included, during which a few questionnaires are completed, followed by an overnight sleep recording using the Apneal application. This will be conducted at the beginning of the care during the assessment phase and again six months after the completion of any potential treatment. Depending on the results, if they are inconclusive, an additional sleep recording may be required using a ventilatory polygraphy device. This study involves only two overnight recordings with a smartphone secured to the chest, which we will set up during the consultation.

Conditions

• Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
• Head and Neck Cancers

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Specialized sleep consultation and overnight recording using the APNEAL application	A sleep consultation with a clinical examination. Completion of several questionnaires: Snoring and sleep quality questionnaire (AFSORL), EORTC Qulity of Life questionnary -C30, and H\&N35. Providing the Apneal application pre-installed on a loaned smartphone for the patient to use at home for overnight recording.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-03-26
• Last updated: 2025-03-26

Locations

1 site across 1 country: France