DysphagiaNCT03082170
The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function
A study testing FEES, SDQ and data review in people with Dysphagia and Sleep Apnea, Obstructive, run by Rambam Health Care Campus.
Trial summary
The investigators hypothesize that partial robotic tongue base resection surgery and / or soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to characterize the dysphagia The investigators will locate participants undergoing this surgery more than six months ago.The… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dysphagia, Sleep Apnea, Obstructive
- What is being tested?
- FEES, SDQ and data review
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 20 Mar 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants above 18 years who had Robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea.
Who cannot join
- participants who previously underwent surgery or treatments known to be hazardous for swallowing.
- participants suffering from a neurological problem that affects the quality of swallowing.
- Tracheostomized participants.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Quality of Postoperative Swallowing After Tongue Base and Palate Surgeries for Obstructive Sleep Apnea.
The investigators hypothesize that partial robotic tongue base resection surgery and / or soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to characterize the dysphagia The investigators will locate participants undergoing this surgery more than six months ago.The investigators will test their swallowing by fiberoptic endoscopic evaluation of swallowing (FEES) and let participants fill out a questionnaire regarding swallowing disorders swallowing dysfunction questionnaire (SDQ). Also the investigators will use data collected from participants who have undergone this surgery and already had these tests due to swallowing complaints.
Read the detailed description
first step: The investigators will review the operating room reports, identify participants who underwent trans-oral robotic surgery for base of tongue and/ or soft palate surgery more than six months ago.
second step:
- The investigators will locate and conclude data of participants who already underwent assessment of postoperative swallowing function (FEES test and SDQ).The investigators will review the summary of their meeting.
- The investigators will Call participants who have not yet done swallowing assessment and invite them to a clinic appointment. third step- participants come to the clinic. Receive an explanation, sign a consent form. Then the participants fulfill the SDQ questionnaire (patient self- filling questionnaire) in which the participants assess the quality swallowing.
Then the investigators will conduct the swallowing test - FEES test. During This test fiber optic fiber is inserted through the participants nose for the purpose of observing the pharyngeal and laryngeal areas.The participants eat and drink food and with different textures while looking for their swallowing mechanism via the optical fiber in order to identify swallowing problems.
forth step- Two laryngologists and a speech therapists will go over the recorded swallowing tests, filling out the two questionnaires:Swallowing performance status scale (SPSS) and Penetration- aspiration scale (PAS).
With these scales every participant receives a score that reflects the quality of swallowing. A higher score indicates a more severe swallowing disorder.
- Conditions
- Dysphagia, Sleep Apnea, Obstructive
- Being tested
- FEES, SDQ, data review
- Keywords
- sleep apnea, robotic surgery for base of tongue, soft palate surgery, post operative swallowing evaluation, dysphagia
- Medical subject headings
- Deglutition Disorders, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEESDevice
FEES test. During this test the investigators look at the pharynx and larynx of the participant while he eats and drinks Economy using number of textures aim to identify swallowing pathology.
SDQDiagnostic test
The participant will fill a questionnaire containing 14 questions.These Questions rigorously test all aspects of the swallowing. High score in this test is consistent with swallowing disorder.
data reviewBehavioural
Reviewing the data from the test summary of participants who have already undergone post operative swallowing assessment.
| Study group | Role | What they receive |
|---|---|---|
| Data review | Other | The investigators will go over the data from the test summary of participants who have already undergone post operative swallowing assessment. Receives: Behavioral: data review |
| FEES and SDQ | Experimental | The participants will undergo six months or more after surgery swallowing assessment which will include the FEES test and the SDQ questionnaire. Receives: Device: FEES; Diagnostic Test: SDQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDQ
Examination of test scores received in the SDQ
Measured: Six months post op
penetration aspiration scale
Examination of test scores received in the penetration aspiration scale
Measured: Six months post operative
swallowing performance status scale
Examination of test scores received in the swallowing performance status scale
Measured: Six months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Jun 2017 (estimated)
- Primary completion20 Nov 2017 (estimated)
- Study completion20 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The investigators would appreciate the quality of swallowing of participants suffering from sleep apnea that had half a year ago or more robotic resection of tongue base or soft palate surgery. The investigators will use the SDQ self reported questionnaire and the FEES test as tools for assessing the participant's swallowing.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norberto krivoy, MD, Study chair, Rambam medical center. Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082170
- Sponsor's protocol ID
- 0587-16-RMB
- Status last verified
- May 2017
- First submitted
- 13 Mar 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data collected are summarized information regarding the swallowing quality of patients as recorded in the FEES test and as reported by the patient in the SDQ questionnaire.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Postoperative Swallowing After Tongue Base and Palate Surgeries for Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT03082170
- Acronym / sponsor ID
- 0587-16-RMB
- Conditions
- Dysphagia, Sleep Apnea, Obstructive
- Keywords
- sleep apnea, robotic surgery for base of tongue, soft palate surgery, post operative swallowing evaluation, dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 20 Nov 2017 (estimated)
- Study completion
- 20 Mar 2018 (estimated)
- First posted
- 17 Mar 2017 (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 investigators hypothesize that partial robotic tongue base resection surgery and / or soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to characterize the dysphagia The investigators will locate participants undergoing this surgery more than six months ago.The investigators will test their swallowing by fiberoptic endoscopic evaluation of swallowing (FEES) and let participants fill out a questionnaire regarding swallowing disorders swallowing dysfunction questionnaire (SDQ). Also the investigators will use data collected from participants who have undergone this surgery and already had these tests due to swallowing complaints.
Detailed description
first step: The investigators will review the operating room reports, identify participants who underwent trans-oral robotic surgery for base of tongue and/ or soft palate surgery more than six months ago.
second step:
- The investigators will locate and conclude data of participants who already underwent assessment of postoperative swallowing function (FEES test and SDQ).The investigators will review the summary of their meeting.
- The investigators will Call participants who have not yet done swallowing assessment and invite them to a clinic appointment. third step- participants come to the clinic. Receive an explanation, sign a consent form. Then the participants fulfill the SDQ questionnaire (patient self- filling questionnaire) in which the participants assess the quality swallowing.
Then the investigators will conduct the swallowing test - FEES test. During This test fiber optic fiber is inserted through the participants nose for the purpose of observing the pharyngeal and laryngeal areas.The participants eat and drink food and with different textures while looking for their swallowing mechanism via the optical fiber in order to identify swallowing problems.
forth step- Two laryngologists and a speech therapists will go over the recorded swallowing tests, filling out the two questionnaires:Swallowing performance status scale (SPSS) and Penetration- aspiration scale (PAS).
With these scales every participant receives a score that reflects the quality of swallowing. A higher score indicates a more severe swallowing disorder.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators would appreciate the quality of swallowing of participants suffering from sleep apnea that had half a year ago or more robotic resection of tongue base or soft palate surgery. The investigators will use the SDQ self reported questionnaire and the FEES test as tools for assessing the participant's swallowing.
| Arm | Type | Receives |
|---|---|---|
| Data review | Other | Behavioral: data reviewThe investigators will go over the data from the test summary of participants who have already undergone post operative swallowing assessment. |
| FEES and SDQ | Experimental | Device: FEES, Diagnostic Test: SDQThe participants will undergo six months or more after surgery swallowing assessment which will include the FEES test and the SDQ questionnaire. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants above 18 years who had Robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea.
Key exclusion criteria (3 listed)
- participants who previously underwent surgery or treatments known to be hazardous for swallowing.
- participants suffering from a neurological problem that affects the quality of swallowing.
- Tracheostomized participants.
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 |
|---|---|---|
| FEESFEES test. During this test the investigators look at the pharynx and larynx of the participant while he eats and drinks Economy using number of textures aim to identify swallowing pathology. | Device | FEES and SDQ |
| SDQThe participant will fill a questionnaire containing 14 questions.These Questions rigorously test all aspects of the swallowing. High score in this test is consistent with swallowing disorder. | Diagnostic test | FEES and SDQ |
| data reviewReviewing the data from the test summary of participants who have already undergone post operative swallowing assessment. | Behavioural | Data review |
Primary outcome
SDQ
Time frame: Six months post op
Examination of test scores received in the SDQ
penetration aspiration scale
Time frame: Six months post operative
Examination of test scores received in the penetration aspiration scale
swallowing performance status scale
Time frame: Six months post operative
Examination of test scores received in the swallowing performance status scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: Undecided. The data collected are summarized information regarding the swallowing quality of patients as recorded in the FEES test and as reported by the patient in the SDQ questionnaire.
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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.
Norberto krivoy, MD study chair
Rambam medical center. Haifa Israel
Questions about this trial
What is this clinical trial studying?
A study testing FEES, SDQ and data review in people with Dysphagia and Sleep Apnea, Obstructive, run by Rambam Health Care Campus.
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 1 inclusion and 3 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Miki Paker, MD (972-52-6596552, chiefmiki2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDQ (time frame: Six months post op). The study lists 3 primary outcomes in all. 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 11 May 2017.