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Clinical Trials/NCT04440618
NCT04440618
Unknown
Not Applicable

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

Poitiers University Hospital1 site in 1 country30 target enrollmentJuly 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea-hypopnea
Sponsor
Poitiers University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 30, 2020
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Severity of OSAHS as a function of the post-therapeutic delay.(Day 28)

Study Sites (1)

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