Obstructive Sleep Apnea SyndromeNCT02881723
Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
A study testing Surgery and Radio- chemotherapy in people with Obstructive Sleep Apnea Syndrome and Oropharyngeal Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Oropharyngeal Cancer
- What is being tested?
- Surgery and Radio- chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Patient aged over 18 years old, male or female;
- Patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated T3 or T4, whatever the stage N and M0;
- Patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy;
- Treatment completed at least 12 months prior to study entry;
- Patient whose cancer disease is under control at exam time;
- Subject affiliated to a social security scheme;
- Subject agreeing to participate in the study and who signed the informed consent form.
Who cannot join
- Minor patient
- No affiliation to a social security scheme (beneficiary or assignee);
- Patient who did not signed the informed consent form
- Patient with neurological disease that can affect the upper airways function
- Patient has already been treated for head and neck cancer;
- Patient has a lesion classified T1 or T2 or M1;
- Patient has received different treatments: surgical resection without reconstruction, only radiotherapy
- Unweaned alcoholic patients
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM
Marseille, 13005
About this study
The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.
Read the detailed description
Obstructive sleep apnea syndrome (OSAS) remains poorly documented in head and neck cancer cancer population, who have a higher risk than the general population. OSAS is a risk factor for quality of life impairment and cardiovascular morbidity and mortality.
This study proposes to carry out an OSAS prevalence study among a locally advanced head and neck cancer population, already treated and to compare the consequences of current therapeutic options in sleep quality.The primary research objective will be a prevalence determination in a locally advanced stages treated population of oropharyngeal cancer. Secondary objectives will be the comparison of the prevalence between the surgical group and the radio-chemotherapy group, the research of predictive factors of presenting an OSAS and the precision of the impact on quality of life.
- Being tested
- Surgery, Radio- chemotherapy
- Medical subject headings
- Sleep Apnea, Obstructive, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Radio- chemotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Treatment for oropharyngeal cancer by surgery | Experimental | Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery Receives: Procedure: Surgery |
| Treatment for oropharyngeal cancer by radio-chemotherapy | Experimental | Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy Receives: Radiation: Radio- chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour
For an IAH <10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH>30: severe OSAS is diagnosed
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionDec 2016 (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 SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881723
- Sponsor's protocol ID
- 2012-25
- Other IDs
- 2012-A00863-40
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
- ClinicalTrials.gov ID
- NCT02881723
- Acronym / sponsor ID
- 2012-25
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- 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 level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.
Detailed description
Obstructive sleep apnea syndrome (OSAS) remains poorly documented in head and neck cancer cancer population, who have a higher risk than the general population. OSAS is a risk factor for quality of life impairment and cardiovascular morbidity and mortality.
This study proposes to carry out an OSAS prevalence study among a locally advanced head and neck cancer population, already treated and to compare the consequences of current therapeutic options in sleep quality.The primary research objective will be a prevalence determination in a locally advanced stages treated population of oropharyngeal cancer. Secondary objectives will be the comparison of the prevalence between the surgical group and the radio-chemotherapy group, the research of predictive factors of presenting an OSAS and the precision of the impact on quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment for oropharyngeal cancer by surgery | Experimental | Procedure: SurgeryDisease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery |
| Treatment for oropharyngeal cancer by radio-chemotherapy | Experimental | Radiation: Radio- chemotherapyDisease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged over 18 years old, male or female;
- Patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated T3 or T4, whatever the stage N and M0;
- Patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy;
- Treatment completed at least 12 months prior to study entry;
- Patient whose cancer disease is under control at exam time;
Key exclusion criteria (8 listed)
- Minor patient
- No affiliation to a social security scheme (beneficiary or assignee);
- Patient who did not signed the informed consent form
- Patient with neurological disease that can affect the upper airways function
- Patient has already been treated for head and neck cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery | Procedure or surgery | Treatment for oropharyngeal cancer by surgery |
| Radio- chemotherapy | Radiation | Treatment for oropharyngeal cancer by radio-chemotherapy |
Primary outcome
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour
Time frame: 1 day
For an IAH <10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH>30: severe OSAS is diagnosed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea Syndrome
RecruitingObservational study
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Catherine GEINDRE study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Radio- chemotherapy in people with Obstructive Sleep Apnea Syndrome and Oropharyngeal Cancer, run by Assistance Publique Hopitaux De Marseille 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 29 Aug 2016. 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?
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?
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour (time frame: 1 day). 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 29 Aug 2016.