Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment

Obstructive Sleep Apnea Syndrome Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02881723
• Other study ID #: 2012-25
• Secondary ID: 2012-A00863-40
• Status: Active, not recruiting
• Phase: N/A
• First received: August 24, 2016
• Last updated: August 24, 2016
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: December 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Procedure:
• Surgery

Radiation:
• Radio- chemotherapy

Locations

Country	Name	City	State
France	Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No