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

November 3, 2023 updated by: Centre Hospitalier Sud Francilien

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

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with a recently discovered upper aerodigestive tract tumour who have not yet started treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after the end of treatment for cancer of the upper aerodigestive tract

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the 6 months follow-up
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.
at 3 months and 6 months
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
6 months after the end of treatment for cancer of the upper aerodigestive tract

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Sandrine Baron, MD, Centre Hospitalier Sud Francilien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02373-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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