The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

NCT ID: NCT03082170

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-03-20

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.

Conditions

Dysphagia; Sleep Apnea, Obstructive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Data review

The investigators will go over the data from the test summary of participants who have already undergone post operative swallowing assessment.

Group Type: OTHER

data review

Intervention Type: BEHAVIORAL

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

FEES and SDQ

The participants will undergo six months or more after surgery swallowing assessment which will include the FEES test and the SDQ questionnaire.

Group Type: EXPERIMENTAL

FEES

Intervention Type: DEVICE

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.

SDQ

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DIAGNOSTIC_TEST

data review

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norberto krivoy, MD

Role: STUDY_CHAIR

Rambam medical center. Haifa Israel

Central Contacts

Miki Paker, MD

Role: CONTACT

chiefmiki2014@gmail.com

972-52-6596552

Jacob Cohen, MD

Role: CONTACT

jacob_cohen@hotmail.com

972-52-4266364

Other Identifiers

0587-16-RMB

Identifier Type: -

Identifier Source: org_study_id