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

Completed

• Conditions: Obstructive Sleep Apnea-hypopnea Syndrome; Upper Aerodigestive Tract Neoplasms

• Registration Number: NCT04262453
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief 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)

Detailed 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).

Study Timeline

• Study Start: 2019-01-21
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of obstructive sleep apnea syndrome	3 months after the end of treatment for cancer of the upper aerodigestive tract	Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour

Secondary Outcome Measures

Name	Time	Method
Epworth score	at 3 months and 6 months	The Epworth auto-questionnaire, rated from 0 (better) to 24 (worse), assess day-time sleapiness.
Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment	during the 6 months follow-up	Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment
Occurence of obstructive sleep apnea syndrome	6 months after the end of treatment for cancer of the upper aerodigestive tract	Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France