Upper Aerodigestive Tract NeoplasmsSAOS-KNCT04262453
Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract
An observational study of Upper Aerodigestive Tract Neoplasms and Obstructive Sleep Apnea-hypopnea Syndrome, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Aerodigestive Tract Neoplasms, Obstructive Sleep Apnea-hypopnea Syndrome
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a recently discovered upper aerodigestive tract tumour who have not yet started treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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).
- Keywords
- Upper Aerodigestive Tract Neoplasms, Obstructive Sleep Apnea-hypopnea Syndrome, Epworth score, Ventilatory Polygraphy
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment
Measured: during the 6 months follow-up
Epworth score
The Epworth auto-questionnaire, rated from 0 (better) to 24 (worse), assess day-time sleapiness.
Measured: at 3 months and 6 months
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
Measured: 6 months after the end of treatment for cancer of the upper aerodigestive tract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start21 Jan 2019
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Aerodigestive Tract NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine Baron, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262453
- Sponsor's protocol ID
- 2018-A02373-52
- Acronym
- SAOS-K
- Status last verified
- Nov 2023
- First submitted
- 9 Dec 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28543072Gilat 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.
PubMed 23575744Loth 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.
PubMed 28332763Faiz 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.
PubMed 25273079
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study
- ClinicalTrials.gov ID
- NCT04262453
- Acronym / sponsor ID
- SAOS-K / 2018-A02373-52
- Keywords
- Upper Aerodigestive Tract Neoplasms, Obstructive Sleep Apnea-hypopnea Syndrome, Epworth score, Ventilatory Polygraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a recently discovered upper aerodigestive tract tumour who have not yet started treatment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment
Time frame: during the 6 months follow-up
Epworth score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Results publication: PubMed 28543072Huyett 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.
- Results publication: PubMed 23575744Gilat 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.
- Results publication: PubMed 28332763Loth 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.
- Results publication: PubMed 25273079Faiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine Baron, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Aerodigestive Tract Neoplasms and Obstructive Sleep Apnea-hypopnea Syndrome, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of obstructive sleep apnea syndrome (time frame: 3 months after the end of treatment for cancer of the upper aerodigestive tract). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262453, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.