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NCT Number: NCT04262453

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

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)

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Key information

Conditions

Upper Aerodigestive Tract Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Obstructive Sleep Apnea-hypopnea Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurence of obstructive sleep apnea syndrome

    Time frame: 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 outcomes

  1. Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment

    Time frame: during the 6 months follow-up

    Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment

  2. Epworth score

    Time frame: at 3 months and 6 months

    The Epworth auto-questionnaire, rated from 0 (better) to 24 (worse), assess day-time sleapiness.

  3. Occurence of obstructive sleep apnea syndrome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: SAOS-K

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2020
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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