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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04440618

Acronym

COROSAS

Enrollment

Registered

2020-06-19

Start date

2020-07-30

Completion date

2021-06-30

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea-hypopnea, Oropharyngeal Cancer

Keywords

combined chemoradiotherapy

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Contacts

Primary ContactXavier DUFOUR, Pr

xavier.dufour@chu-poitiers.fr05 49 44 33 89

Backup ContactEleonore CHARY, Dr

Outcome results