Obstructive Sleep Apnea-hypopneaCOROSASNCT04440618
Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy
An observational study of Obstructive Sleep Apnea-hypopnea and Oropharyngeal Cancer, run by Poitiers University Hospital at 1 site in France.
Trial summary
The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea-hypopnea, Oropharyngeal Cancer
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2020to 30 Jun 2021
- 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: Disease-free patients treated for locally advanced oropharyngeal cancer for over 6 months by radio-chemotherapy.
Who may be able to join
- Age> 18 years old
- Performance Status 0-2
- Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy
- Treatment termination time greater than 6 months at inclusion
- Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3
- Patient in complete remission at inclusion
- patient's consent's obtained after information
Who cannot join
- Previous treatment for upper aerodigestive tract cancer
- Incomplete radiotherapyTreatment
- Neurological pathology wich may affect the functions of the upper aerodigestive tract
- Pregnant or breastfeeding woman
- Unweaned alcoholism
- Tracheotomized patient at the time of the study
- Patient under protection: subjects with guardianship or under law protection
- No health insurance coverage
Trial locations and contacts
1 site in 1 country.
Eleonore CHARY, Dr contact
France1 site, 1 recruiting
- Recruiting
CHU Poitiers
Poitiers, 86000
Eleonore CHARY, Dr, 05 49 44 33 89 ext. 33
About this study
The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.
- Keywords
- combined chemoradiotherapy
- Medical subject headings
- Oropharyngeal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.
Measured: Day 28
Secondary outcomes (1)
Severity of OSAHS as a function of the post-therapeutic delay.
Value of the AHI as a function of the post-therapeutic delay which corresponds to the delay compared to the end of the curative treatment carried out for squamous cell carcinoma of the oropharynx. It is obtained after the inclusion visit and the realization of the polygraphy with the IAH score. OSAHS is mild (if IAH ≥ 5 / h and <15 / h), moderate (if IAH ≥ 15 / h and ≤ 30 / h) or severe (if IAH> 30 / h)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start30 Jul 2020
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea-hypopneaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440618
- Sponsor's protocol ID
- COROSAS
- Acronym
- COROSAS
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT04440618
- Acronym / sponsor ID
- COROSAS / COROSAS
- Keywords
- combined chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 19 Jun 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.
The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Disease-free patients treated for locally advanced oropharyngeal cancer for over 6 months by radio-chemotherapy.
Key inclusion criteria (7 listed)
- Age> 18 years old
- Performance Status 0-2
- Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy
- Treatment termination time greater than 6 months at inclusion
- Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3
Key exclusion criteria (8 listed)
- Previous treatment for upper aerodigestive tract cancer
- Incomplete radiotherapyTreatment
- Neurological pathology wich may affect the functions of the upper aerodigestive tract
- Pregnant or breastfeeding woman
- Unweaned alcoholism
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
Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
Time frame: Day 28
Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.
1 secondary outcome
Severity of OSAHS as a function of the post-therapeutic delay.
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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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.
Eleonore CHARY, Dr contact
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 Obstructive Sleep Apnea-hypopnea and Oropharyngeal Cancer, run by Poitiers University Hospital 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier DUFOUR, Pr (05 49 44 33 89 ext. 33, xavier.dufour@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2021.