The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo (OSATDV)

December 25, 2016 updated by: Oron Yahav, Wolfson Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Wolfson Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

December 25, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0103-15-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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