Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract

Upper Aerodigestive Tract Neoplasms Clinical Trial

— SAOS-K  

Official title:

Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262453
• Other study ID #: 2018-A02373-52
• Status: Completed
• Start date: January 21, 2019
• Est. completion date: September 20, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Description:

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. Patients are included in the study when they are hospitalized for panendoscopy. Thereafter, it takes about 1 month to start any treatment. The duration of treatment is estimated at about 5 months (the longest regimen would be induction chemotherapy followed by surgery and adjuvant complementary treatment). After which 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Apnea
• Head and Neck Neoplasms
• Obstructive Sleep Apnea-hypopnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome
• Upper Aerodigestive Tract Neoplasms

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (4)

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

Outcome

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