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NCT06896448Recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
10 Mar 2025
Start date
16 Sept 2025
Primary completion date
16 Sept 2027
Lead sponsor
University Hospital, Caen
NCT number
NCT06896448

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 16 Sept 2025 to the primary completion date, 16 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known history of obstructive sleep apnea syndrome (OSAS) or previously treated head and neck cancer.

Other illness

  • Lack of confirmation of the malignant nature of the lesion.
  • Diagnosis of metastatic cancer.

Other

  • Minor patients, or those under judicial protection, guardianship, or curators.

Who the study is looking for

  • Adult patients undergoing diagnostic workup for a lesion suspected to be a head and neck cancer, followed by confirmation of the malignant nature of the lesion. The following locations will be included: the nasopharynx, nasal cavities, sinuses, oral cavity, oropharynx, hypopharynx, larynx, and parotid gland.
  • The collection of the informed consent signature is required.
  • The patient must be affiliated with the social security system.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.