NCT04262453

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

4.7 years

First QC Date

December 9, 2019

Last Update Submit

November 3, 2023

Conditions

Upper Aerodigestive Tract NeoplasmsObstructive Sleep Apnea-hypopnea Syndrome

Keywords

Upper Aerodigestive Tract NeoplasmsObstructive Sleep Apnea-hypopnea SyndromeEpworth scoreVentilatory Polygraphy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    during the 6 months follow-up

  • Epworth score

    at 3 months and 6 months

  • Occurence of obstructive sleep apnea syndrome

    6 months after the end of treatment for cancer of the upper aerodigestive tract

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Related Publications (4)

  • 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.

    PMID: 28543072RESULT

  • 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.

    PMID: 23575744RESULT

  • 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):1281-1288. doi: 10.1111/coa.12869. Epub 2017 Apr 18.

    PMID: 28332763RESULT

  • 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 1.

    PMID: 25273079RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Sandrine Baron, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

February 10, 2020

Study Start

January 21, 2019

Primary Completion

September 20, 2023

Study Completion

September 20, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)