The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

Rambam Health Care Campus

Status: Unknown

Conditions: Dysphagia; Sleep Apnea, Obstructive

Treatments: Behavioral: data review; Diagnostic Test: SDQ; Device: FEES

Study type: Interventional

Funder types: Other

Identifiers

NCT03082170

0587-16-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Data review

Other group

Description:

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

Treatment:

Behavioral: data review

FEES and SDQ

Experimental group

Description:

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

Treatment:

Device: FEES

Diagnostic Test: SDQ