NCT04440618UnknownNot 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 enrollmentStarted: July 30, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Poitiers University Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (1)
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