The Effect of Obstructive Sleep Apnea Operations on the S... | NCT03082170

Studies
The Effect of Obstructive Sleep Apnea Operations on the Swallowing Function

NCT03082170

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

May 11, 2017Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Dysphagia
Sleep Apnea, Obstructive

Interventions

FEES
SDQ
data review

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Estimated

Primary Completion Date

Nov 20, 2017Estimated

Completion Date

Mar 20, 2018Estimated

First Submitted Date

Mar 13, 2017

First Submission Date that Met QC Criteria

Mar 13, 2017

First Posted Date

Mar 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2017

Last Update Posted Date

May 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miki Paker, MD	Contact	972-52-6596552		chiefmiki2014@gmail.com
Jacob Cohen, MD	Contact	972-52-4266364		jacob_cohen@hotmail.com

Overall Officials

Name	Affiliation	Role
Norberto krivoy, MD	Rambam medical center. Haifa Israel	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.