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

NCT ID: NCT06896448

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Patients with head and neck cancers

Group Type: EXPERIMENTAL

Specialized sleep consultation and overnight recording using the APNEAL application

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Minor patients, or those under judicial protection, guardianship, or curators.
• Lack of confirmation of the malignant nature of the lesion.
• Diagnosis of metastatic cancer.
• Known history of obstructive sleep apnea syndrome (OSAS) or previously treated head and neck cancer.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitral

INDUSTRY

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Caen

Caen, France, France

Countries

France

Central Contacts

Emmanuel MICAULT, Dr

Role: CONTACT

micault-e@chu-caen.fr

+33231065461

Facility Contacts

BALUTA Lisa, intern

Role: primary

baluta-l@chu-caen.fr

+33231065461

Emmanuel MICAULT, Dr

Role: backup

micault-e@chu-caen.fr

Other Identifiers

24-0233

Identifier Type: -

Identifier Source: org_study_id