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

• Conditions: Oropharyngeal Cancer; Obstructive Sleep Apnea-hypopnea

• Registration Number: NCT04440618
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Study Start: 2020-07-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14
• Primary Completion: 2021-05-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France