Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy (COROSAS)

January 13, 2021 updated by: Poitiers University Hospital
The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Eleonore CHARY, Dr

Study Locations

  • France
      • Poitiers, France, 86000
        • Recruiting
        • CHU Poitiers
        • Contact:
          • Eleonore CHARY, Dr
          • Phone Number: 33 05 49 44 33 89

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Disease-free patients treated for locally advanced oropharyngeal cancer for over 6 months by radio-chemotherapy.

Description

Inclusion Criteria:

  • Age> 18 years old
  • Performance Status 0-2
  • Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy
  • Treatment termination time greater than 6 months at inclusion
  • Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3
  • Patient in complete remission at inclusion
  • patient's consent's obtained after information

Exclusion Criteria:

  • Previous treatment for upper aerodigestive tract cancer
  • Incomplete radiotherapyTreatment
  • Neurological pathology wich may affect the functions of the upper aerodigestive tract
  • Pregnant or breastfeeding woman
  • Unweaned alcoholism
  • Tracheotomized patient at the time of the study
  • Patient under protection: subjects with guardianship or under law protection
  • No health insurance coverage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
Time Frame: Day 28
Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of OSAHS as a function of the post-therapeutic delay.
Time Frame: Day 28
Value of the AHI as a function of the post-therapeutic delay which corresponds to the delay compared to the end of the curative treatment carried out for squamous cell carcinoma of the oropharynx. It is obtained after the inclusion visit and the realization of the polygraphy with the IAH score. OSAHS is mild (if IAH ≥ 5 / h and <15 / h), moderate (if IAH ≥ 15 / h and ≤ 30 / h) or severe (if IAH> 30 / h)
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Anticipated)

May 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COROSAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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