NCT02685579

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

February 13, 2016

Last Update Submit

December 25, 2016

Conditions

Sleep ApneaDizzinessVertigo

Outcome Measures

Primary Outcomes (1)

  • Dizziness Handicap Inventory Score

    A change in the DHI score after treatment (before treatment and after, 3 months in between)

    3 months

Secondary Outcomes (1)

  • Romberg on foam test

    3 months

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Centre

Holon, Israel

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesDizzinessVertigo

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ENT Specialist

Study Record Dates

First Submitted

February 13, 2016

First Posted

February 18, 2016

Study Start

June 1, 2016

Primary Completion

March 1, 2018

Last Updated

December 28, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)