Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)NCT06896448
Innovative OSA Screening in Head and Neck Cancer Patients With the Apneal App
A study testing Specialized sleep consultation and overnight recording using the APNEAL application in people with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Head and Neck Cancers, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS), Head and Neck Cancers
- What is being tested?
- Specialized sleep consultation and overnight recording using the APNEAL application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2025to 16 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Caen
Caen, France, 14000
BALUTA Lisa, intern, +33231065461, baluta-l@chu-caen.fr
Emmanuel MICAULT, Dr, micault-e@chu-caen.fr
About this study
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.
Read more
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.
- Being tested
- Specialized sleep consultation and overnight recording using the APNEAL application
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized sleep consultation and overnight recording using the APNEAL applicationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with head and neck cancers | Experimental | Not described Receives: Diagnostic Test: Specialized sleep consultation and overnight recording using the APNEAL application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the rate of usable collected data at 6 months after treatment, with an interim analysis after the first consultation and initial recording, meaning a given Apnea-Hypopnea Index (AHI) from at least 6 hours of overnight recording
Study the feasibility of screening for obstructive sleep apnea syndrome (OSAS) in clinical practice among patients with head and neck cancer using the Apneal application, which is currently under validation The patient is treated during around 2 months and the night recording will be at 3 and 6 months after the end of the treatment The number of the recording nights with at least 4 hours records will be calculated
Measured: 8 months
Secondary outcomes (2)
Measurement of the evolution of the AHI score during patient management, comparing the first recording with the second one performed six months after treatment completion
Study the incidence of obstructive sleep apnea syndrome (OSAS) in patients treated for head and neck cancer, based on the therapeutic strategy used, to identify patient profiles at higher risk of developing OSAS The IHA score will be compared
IHA score :
< 5 : no OSAS 5-15 : mild OSAS 15-30 : moderate OSAS > 30 : severe OSAS
First recording at the inclusion, then 2 months of treatment and 6 months after the end of the treatment, another recording
Measured: 8 months
Measurement of the evolution of quality of life criteria by comparing the initial questionnaires completed during the first consultation with those completed 6 months after treatment
Study the impact of obstructive sleep apnea syndrome (OSAS) on the quality of life in patients treated for head and neck cancer with the EORTC QLQ H\&N35
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start16 Sep 2025
- Primary completion16 Sep 2027 (estimated)
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Mitral
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896448
- Sponsor's protocol ID
- 24-0233
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative OSA Screening in Head and Neck Cancer Patients With the Apneal App
- ClinicalTrials.gov ID
- NCT06896448
- Acronym / sponsor ID
- 24-0233
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Mitral
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with head and neck cancers | Experimental | Diagnostic Test: Specialized sleep consultation and overnight recording using the APNEAL application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized sleep consultation and overnight recording using the APNEAL applicationA 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. | Diagnostic test | Patients with head and neck cancers |
Primary outcome
Measurement of the rate of usable collected data at 6 months after treatment, with an interim analysis after the first consultation and initial recording, meaning a given Apnea-Hypopnea Index (AHI) from at least 6 hours of overnight recording
Time frame: 8 months
Study the feasibility of screening for obstructive sleep apnea syndrome (OSAS) in clinical practice among patients with head and neck cancer using the Apneal application, which is currently under validation The patient is treated during around 2 months and the night recording will be at 3 and 6 months after the end of the treatment The number of the recording nights with at least 4 hours records will be calculated
2 secondary outcomes
Measurement of the evolution of the AHI score during patient management, comparing the first recording with the second one performed six months after treatment completion
Time frame: 8 months
Measurement of the evolution of quality of life criteria by comparing the initial questionnaires completed during the first consultation with those completed 6 months after treatment
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized sleep consultation and overnight recording using the APNEAL application in people with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Head and Neck Cancers, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel MICAULT, Dr (+33231065461, micault-e@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the rate of usable collected data at 6 months after treatment, with an interim analysis after the first consultation and initial recording, meaning a given Apnea-Hypopnea Index (AHI) from at least 6 hours of overnight recording (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.