The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03082170
• Other study ID #: 0587-16-RMB
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2017
• Last updated: May 10, 2017
• Start date: June 1, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: May 2017
• Source: Rambam Health Care Campus
• Contact: Miki Paker, MD
• Phone: 972-52-6596552
• Email: chiefmiki2014[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 20, 2018
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Deglutition Disorders
• Dysphagia
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• FEES
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 Test:
• SDQ
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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SDQ	Examination of test scores received in the SDQ	Six months post op
Primary	penetration aspiration scale	Examination of test scores received in the penetration aspiration scale	Six months post operative
Primary	swallowing performance status scale	Examination of test scores received in the swallowing performance status scale	Six months post operative