search
Back to results

The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

Primary Purpose

Dysphagia, Sleep Apnea, Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FEES
SDQ
data review
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dysphagia focused on measuring sleep apnea, robotic surgery for base of tongue, soft palate surgery, post operative swallowing evaluation, dysphagia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Data review

    FEES and SDQ

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    SDQ
    Examination of test scores received in the SDQ
    penetration aspiration scale
    Examination of test scores received in the penetration aspiration scale
    swallowing performance status scale
    Examination of test scores received in the swallowing performance status scale

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2017
    Last Updated
    May 10, 2017
    Sponsor
    Rambam Health Care Campus
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03082170
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    November 20, 2017 (Anticipated)
    Study Completion Date
    March 20, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia, Sleep Apnea, Obstructive
    Keywords
    sleep apnea, robotic surgery for base of tongue, soft palate surgery, post operative swallowing evaluation, dysphagia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Data review
    Arm Type
    Other
    Arm Description
    The investigators will go over the data from the test summary of participants who have already undergone post operative swallowing assessment.
    Arm Title
    FEES and SDQ
    Arm Type
    Experimental
    Arm Description
    The participants will undergo six months or more after surgery swallowing assessment which will include the FEES test and the SDQ questionnaire.
    Intervention Type
    Device
    Intervention Name(s)
    FEES
    Intervention Description
    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
    Diagnostic Test
    Intervention Name(s)
    SDQ
    Intervention Description
    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
    Behavioral
    Intervention Name(s)
    data review
    Intervention Description
    Reviewing the data from the test summary of participants who have already undergone post operative swallowing assessment.
    Primary Outcome Measure Information:
    Title
    SDQ
    Description
    Examination of test scores received in the SDQ
    Time Frame
    Six months post op
    Title
    penetration aspiration scale
    Description
    Examination of test scores received in the penetration aspiration scale
    Time Frame
    Six months post operative
    Title
    swallowing performance status scale
    Description
    Examination of test scores received in the swallowing performance status scale
    Time Frame
    Six months post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miki Paker, MD
    Phone
    972-52-6596552
    Email
    chiefmiki2014@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacob Cohen, MD
    Phone
    972-52-4266364
    Email
    jacob_cohen@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Norberto krivoy, MD
    Organizational Affiliation
    Rambam medical center. Haifa Israel
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The data collected are summarized information regarding the swallowing quality of patients as recorded in the FEES test and as reported by the patient in the SDQ questionnaire.

    Learn more about this trial

    The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

    We'll reach out to this number within 24 hrs