Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy
COROSAS
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedStudy Start
First participant enrolled
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJanuary 14, 2021
January 1, 2021
10 months
June 17, 2020
January 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.
Day 28
Secondary Outcomes (1)
Severity of OSAHS as a function of the post-therapeutic delay.
Day 28
Eligibility Criteria
Disease-free patients treated for locally advanced oropharyngeal cancer for over 6 months by radio-chemotherapy.
You may qualify if:
- Age\> 18 years old
- Performance Status 0-2
- Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy
- Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3
- patient's consent's obtained after information
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Poitiers
Poitiers, 86000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Eleonore CHARY, Dr
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 19, 2020
Study Start
July 30, 2020
Primary Completion
May 30, 2021
Study Completion
June 30, 2021
Last Updated
January 14, 2021
Record last verified: 2021-01