Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
2 other identifiers
interventional
51
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 24, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 29, 2016
August 1, 2016
1.9 years
August 24, 2016
August 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Treatment for oropharyngeal cancer by surgery
EXPERIMENTALDisease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery
Treatment for oropharyngeal cancer by radio-chemotherapy
EXPERIMENTALDisease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM
Marseille, 13005, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine GEINDRE
Assistance Publique Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2016
First Posted
August 29, 2016
Study Start
March 1, 2013
Primary Completion
February 1, 2015
Study Completion
December 1, 2016
Last Updated
August 29, 2016
Record last verified: 2016-08