- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02881723
Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Marseille, Frankrig, 13005
- Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient aged over 18 years old, male or female;
- Patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated T3 or T4, whatever the stage N and M0;
- Patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy;
- Treatment completed at least 12 months prior to study entry;
- Patient whose cancer disease is under control at exam time;
- Subject affiliated to a social security scheme;
- Subject agreeing to participate in the study and who signed the informed consent form.
Exclusion Criteria:
- Minor patient
- No affiliation to a social security scheme (beneficiary or assignee);
- Patient who did not signed the informed consent form
- Patient with neurological disease that can affect the upper airways function
- Patient has already been treated for head and neck cancer;
- Patient has a lesion classified T1 or T2 or M1;
- Patient has received different treatments: surgical resection without reconstruction, only radiotherapy
- Unweaned alcoholic patients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Treatment for oropharyngeal cancer by surgery
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery
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Eksperimentel: Treatment for oropharyngeal cancer by radio-chemotherapy
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour
Tidsramme: 1 day
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For an IAH <10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH>30: severe OSAS is diagnosed
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1 day
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Neoplasmer
- Apnø
- Respirationsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvågningsforstyrrelser
- Neoplasmer efter sted
- Sygdom
- Pharyngeale neoplasmer
- Otorhinolaryngologiske neoplasmer
- Neoplasmer i hoved og hals
- Pharyngeale sygdomme
- Stomatognatiske sygdomme
- Otorhinolaryngologiske sygdomme
- Søvnapnø syndromer
- Søvnapnø, obstruktiv
- Syndrom
- Orofaryngeale neoplasmer
Andre undersøgelses-id-numre
- 2012-25
- 2012-A00863-40 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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