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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04262453
Acronym
SAOS-K
Enrollment
142
Registered
2020-02-10
Start date
2019-01-21
Completion date
2023-09-20
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea-hypopnea Syndrome, Upper Aerodigestive Tract Neoplasms

Keywords

Upper Aerodigestive Tract Neoplasms, Obstructive Sleep Apnea-hypopnea Syndrome, Epworth score, Ventilatory Polygraphy

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).

Interventions

None listed

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurence of obstructive sleep apnea syndrome3 months after the end of treatment for cancer of the upper aerodigestive tractObstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour

Secondary

MeasureTime frameDescription
Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatmentduring the 6 months follow-upDelay in onset of obstructive sleep apnea syndrome after completion of cancer treatment
Epworth scoreat 3 months and 6 monthsThe Epworth auto-questionnaire, rated from 0 (better) to 24 (worse), assess day-time sleapiness.
Occurence of obstructive sleep apnea syndrome6 months after the end of treatment for cancer of the upper aerodigestive tractObstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026