The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

NCT03082170 | Unknown DMC

• 1 other identifier: 0587-16-RMB
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysphagia; Sleep Apnea, Obstructive

Keywords

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

Outcome Measures

Primary Outcomes (3)

• SDQ

  Examination of test scores received in the SDQ

  Six months post op

• penetration aspiration scale

  Examination of test scores received in the penetration aspiration scale

  Six months post operative

• swallowing performance status scale

  Examination of test scores received in the swallowing performance status scale

  Six months post operative

Study Arms (2)

Data review

OTHER

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

Behavioral: data review

FEES and SDQ

EXPERIMENTAL

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

Device: FEES; Diagnostic Test: SDQ

Interventions

FEES 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.

FEES and SDQ

SDQ 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.

FEES and SDQ

data review BEHAVIORAL

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

Data review

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants above 18 years who had Robotic base of tongue surgery and/or soft palate surgery as a treatment for obstructive sleep apnea.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Deglutition Disorders; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Norberto krivoy, MD

  Rambam medical center. Haifa Israel

  STUDY CHAIR

Central Study Contacts

Miki Paker, MD

CONTACT

972-52-6596552; chiefmiki2014@gmail.com

Jacob Cohen, MD

CONTACT

972-52-4266364; jacob_cohen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: June 1, 2017
• Primary Completion: November 20, 2017
• Study Completion: March 20, 2018
• Last Updated: May 11, 2017

Record last verified: 2017-05