Upper Aerodigestive Tract Neoplasms Clinical Trial
— SAOS-KOfficial title:
Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study
Verified date | November 2023 |
Source | Centre Hospitalier Sud Francilien |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract. The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)
Status | Completed |
Enrollment | 142 |
Est. completion date | September 20, 2023 |
Est. primary completion date | September 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - macroscopic lesion suggestive of a cancerous tumour of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, cavum, cervical lymph node metastases with an occult primary cancer) - awaiting anatomopathological confirmation Exclusion Criteria: - history of cancer of the upper aerodigestive tract - history of known obstructive sleep apnea syndrome - cancer of the thyroid, salivary glands, nose and paranasal sinuses - patients under guardianship or curatorship |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Sud Francilien | Corbeil-Essonnes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Sud Francilien |
France,
Faiz SA, Balachandran D, Hessel AC, Lei X, Beadle BM, William WN Jr, Bashoura L. Sleep-related breathing disorders in patients with tumors in the head and neck region. Oncologist. 2014 Nov;19(11):1200-6. doi: 10.1634/theoncologist.2014-0176. Epub 2014 Oct — View Citation
Gilat H, Shpitzer T, Guttman D, Soudry E, Feinmesser R, Bachar G. Obstructive sleep apnea after radial forearm free flap reconstruction of the oral tongue. Laryngoscope. 2013 Dec;123(12):3223-6. doi: 10.1002/lary.24125. Epub 2013 Apr 10. — View Citation
Huyett P, Kim S, Johnson JT, Soose RJ. Obstructive sleep apnea in the irradiated head and neck cancer patient. Laryngoscope. 2017 Nov;127(11):2673-2677. doi: 10.1002/lary.26674. Epub 2017 May 23. — View Citation
Loth A, Michel J, Giorgi R, Santini L, Rey M, Elbaum JM, Roux N, Giovanni A, Dessi P, Fakhry N. Prevalence of obstructive sleep apnoea syndrome following oropharyngeal cancer treatment: A prospective cohort study. Clin Otolaryngol. 2017 Dec;42(6):1281-128 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurence of obstructive sleep apnea syndrome | Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour | 3 months after the end of treatment for cancer of the upper aerodigestive tract | |
Secondary | Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment | Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment | during the 6 months follow-up | |
Secondary | Epworth score | The Epworth auto-questionnaire, rated from 0 (better) to 24 (worse), assess day-time sleapiness. | at 3 months and 6 months | |
Secondary | Occurence of obstructive sleep apnea syndrome | Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour | 6 months after the end of treatment for cancer of the upper aerodigestive tract |
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