The Effect of Obstructive Sleep Apnea Treatment on Dizzin... | NCT02685579

Studies
The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo

NCT02685579

Sponsor

Wolfson Medical Center

Status

Withdrawn

Last Update Posted

Dec 28, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Sleep Apnea
Dizziness
Vertigo

Interventions

Treatment of Obstructive Sleep Apnea-CPAP/BiPAP etc./Diet/surgery/life style changes

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Mar 2018Estimated

Completion Date

Not provided

First Submitted Date

Feb 13, 2016

First Submission Date that Met QC Criteria

Feb 17, 2016

First Posted Date

Feb 18, 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

Dec 25, 2016

Last Update Posted Date

Dec 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Treatment of Obstructive Sleep Apnea-CPAP/BiPAP etc./Diet/surgery/life style changes	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dizziness Handicap Inventory Score	A change in the DHI score after treatment (before treatment and after, 3 months in between)	3 months

Secondary Outcomes

Measure	Description	Time Frame
Romberg on foam test	A change in the time participants will stand without falling on a foam (before treatment and after, 3 months in between)	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years old
Diagnosed with Sleep Apnea
DHI score equals or over 16 points

Exclusion Criteria:

Pregnant women
Patients diagnosed with mental diseases
Patients taking anti-vertigo medications
Patients after CVA or with peripheral neuropathy
Patients who suffered severe head trauma
Patients with chronic renal failure
Patients with malignancy at the time of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People coming to the Sleep Study Laboratory at the E. Wolfson Medical Center

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D004244	Dizziness
D014717	Vertigo

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided