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

Sponsor

Poitiers University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04440618

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea-hypopnea Oropharyngeal Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 30, 2020

Anticipated Primary Completion Date :

May 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Outcome Measures

Primary Outcome Measures

Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy. [Day 28]
Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.

Secondary Outcome Measures

Severity of OSAHS as a function of the post-therapeutic delay. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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