Clinical trial NCT03082170: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Sleep Apnea, Obstructive
Keywords: sleep apnea
robotic surgery for base of tongue
soft palate surgery
post operative swallowing evaluation
dysphagia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: SDQ
timeFrame: Six months post op
measure: penetration aspiration scale
timeFrame: Six months post operative
measure: swallowing performance status scale
timeFrame: Six months post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam medical center. Haifa Israel
name: Norberto krivoy, MD
role: STUDY_CHAIR
References: