Long Follow up on Patients With Obstructive Sleep Apnea T... | NCT02976207

Studies
Long Follow up on Patients With Obstructive Sleep Apnea That Undergo Diagnosis and Surgical Treatment

NCT02976207

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Nov 30, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

Israel

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

Nov 2016

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

Jan 2017

Primary Completion Date

Jan 2020Estimated

Completion Date

Not provided

First Submitted Date

Nov 8, 2016

First Submission Date that Met QC Criteria

Nov 24, 2016

First Posted Date

Nov 29, 2016Estimated

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

Nov 29, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Description Module

Brief Summary

Long follow up on patients with obstructive sleep apnea that undergo diagnosis and surgical treatment

Detailed Description

Drug induced sleep endoscopy (DISE) is increasingly performed procedure, offering dynamic upper airway evaluation during artificial sleep before surgical treatment for patients with obstructed

.)OSA(sleep apnea

Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with snoring and OSA DISE is a safe procedure, easily practicable, valid and reliable. We consider it a fundamental clinical procedure that is essential before choosing the surgical treatment. Our results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. We think that the weight did not play a significant role in RDI (Respiratory Disturbance Index) reduction. Our results till now show tailored surgery based on DISE may leverage sleep surgeries outcome significantly presenting 70% success rate based
on our experience We therefore want to evaluate the patients in a long follow up period

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OSA diagnosed patients		patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of daytime sleepiness- using Epworth sleepiness scale questionnaire		up to 3 years after surgery
Sleep quality assessment questionnaire		up to 3 years after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fully diagnosed patients with OSA.
Patients who are candidates for a surgery as a treatment to their condition.

Exclusion Criteria:

Pregnancy
Patients who are not OSA surgery candidates.
Patients with high surgical risk.
Patients with hematological or oncological background.

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

patients at the age range of 18-90, male or female, who are diagnosed as suffering from OSA and are surgery candidates for their condition.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yafe medical center		Hadera	Hadera		Israel