Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea Syndrome; Oropharyngeal Cancer
• Intervention / Treatment: Procedure: Surgery; Radiation: Radio- chemotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment for oropharyngeal cancer by surgery; Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery	Procedure: Surgery
Experimental: Treatment for oropharyngeal cancer by radio-chemotherapy; Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy	Radiation: Radio- chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Estimate): August 29, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neoplasms by Site; Disease; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Oropharyngeal Neoplasms
• Other Study ID Numbers: 2012-25; 2012-A00863-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED