The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function
Primary Purpose
Dysphagia, Sleep Apnea, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FEES
SDQ
data review
Sponsored by
About this trial
This is an interventional diagnostic trial for Dysphagia focused on measuring sleep apnea, robotic surgery for base of tongue, soft palate surgery, post operative swallowing evaluation, dysphagia
Eligibility Criteria
Inclusion Criteria:
- participants above 18 years who had Robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Data review
FEES and SDQ
Arm Description
The investigators will go over the data from the test summary of participants who have already undergone post operative swallowing assessment.
The participants will undergo six months or more after surgery swallowing assessment which will include the FEES test and the SDQ questionnaire.
Outcomes
Primary Outcome Measures
SDQ
Examination of test scores received in the SDQ
penetration aspiration scale
Examination of test scores received in the penetration aspiration scale
swallowing performance status scale
Examination of test scores received in the swallowing performance status scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03082170
Brief Title
The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function
Official Title
Quality of Postoperative Swallowing After Tongue Base and Palate Surgeries for Obstructive Sleep Apnea.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
November 20, 2017 (Anticipated)
Study Completion Date
March 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Sleep Apnea, Obstructive
Keywords
sleep apnea, robotic surgery for base of tongue, soft palate surgery, post operative swallowing evaluation, dysphagia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Data review
Arm Type
Other
Arm Description
The investigators will go over the data from the test summary of participants who have already undergone post operative swallowing assessment.
Arm Title
FEES and SDQ
Arm Type
Experimental
Arm Description
The participants will undergo six months or more after surgery swallowing assessment which will include the FEES test and the SDQ questionnaire.
Intervention Type
Device
Intervention Name(s)
FEES
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
SDQ
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
data review
Intervention Description
Reviewing the data from the test summary of participants who have already undergone post operative swallowing assessment.
Primary Outcome Measure Information:
Title
SDQ
Description
Examination of test scores received in the SDQ
Time Frame
Six months post op
Title
penetration aspiration scale
Description
Examination of test scores received in the penetration aspiration scale
Time Frame
Six months post operative
Title
swallowing performance status scale
Description
Examination of test scores received in the swallowing performance status scale
Time Frame
Six months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participants above 18 years who had Robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Paker, MD
Phone
972-52-6596552
Email
chiefmiki2014@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Cohen, MD
Phone
972-52-4266364
Email
jacob_cohen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norberto krivoy, MD
Organizational Affiliation
Rambam medical center. Haifa Israel
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
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.
Learn more about this trial
The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function
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