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The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

Quality of Postoperative Swallowing After Tongue Base and Palate Surgeries for Obstructive Sleep Apnea.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03082170
Enrollment
120
Registered
2017-03-17
Start date
2017-06-01
Completion date
2018-03-20
Last updated
2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Sleep Apnea, Obstructive

Keywords

sleep apnea, robotic surgery for base of tongue, soft palate surgery, post operative swallowing evaluation, dysphagia

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: 1. 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. 2. 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.

Interventions

DEVICEFEES

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.

DIAGNOSTIC_TESTSDQ

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.

BEHAVIORALdata review

Reviewing the data from the test summary of participants who have already undergone post operative swallowing assessment.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
SDQSix months post opExamination of test scores received in the SDQ
penetration aspiration scaleSix months post operativeExamination of test scores received in the penetration aspiration scale
swallowing performance status scaleSix months post operativeExamination of test scores received in the swallowing performance status scale

Contacts

Primary ContactMiki Paker, MD
chiefmiki2014@gmail.com972-52-6596552
Backup ContactJacob Cohen, MD
jacob_cohen@hotmail.com972-52-4266364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026