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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00863-40 | Other Identifier | ANSM |
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The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.
Obstructive sleep apnea syndrome (OSAS) remains poorly documented in head and neck cancer cancer population, who have a higher risk than the general population. OSAS is a risk factor for quality of life impairment and cardiovascular morbidity and mortality.
This study proposes to carry out an OSAS prevalence study among a locally advanced head and neck cancer population, already treated and to compare the consequences of current therapeutic options in sleep quality.The primary research objective will be a prevalence determination in a locally advanced stages treated population of oropharyngeal cancer. Secondary objectives will be the comparison of the prevalence between the surgical group and the radio-chemotherapy group, the research of predictive factors of presenting an OSAS and the precision of the impact on quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment for oropharyngeal cancer by surgery | Experimental | Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery |
|
| Treatment for oropharyngeal cancer by radio-chemotherapy | Experimental | Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure |
| ||
| Radio- chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour | For an IAH <10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH>30: severe OSAS is diagnosed | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine GEINDRE | Assistance Publique Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM | Marseille | 13005 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Radiation |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |