Sleep ApneaOSATDVNCT02685579
The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo
An observational study of Sleep Apnea and Dizziness, run by Wolfson Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Dizziness, Vertigo
- What is being tested?
- Treatment of Obstructive Sleep Apnea-CPAP/BiPAP etc./Diet/surgery/life style changes
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People coming to the Sleep Study Laboratory at the E. Wolfson Medical Center
Who may be able to join
- Over 18 years old
- Diagnosed with Sleep Apnea
- DHI score equals or over 16 points
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep Apnea, Dizziness, Vertigo
- Being tested
- Treatment of Obstructive Sleep Apnea-CPAP/BiPAP etc./Diet/surgery/life style changes
- Medical subject headings
- Sleep Apnea Syndromes, Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Obstructive Sleep Apnea-CPAP/BiPAP etc./Diet/surgery/life style changesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory Score
A change in the DHI score after treatment (before treatment and after, 3 months in between)
Measured: 3 months
Secondary outcomes (1)
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oron Yahav, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685579
- Sponsor's protocol ID
- 0103-15-WOMC
- Acronym
- OSATDV
- Status last verified
- Dec 2016
- First submitted
- 13 Feb 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo
- ClinicalTrials.gov ID
- NCT02685579
- Acronym / sponsor ID
- OSATDV / 0103-15-WOMC
- Conditions
- Sleep Apnea, Dizziness, Vertigo
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jun 2016
- Primary completion
- Mar 2018 (estimated)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People coming to the Sleep Study Laboratory at the E. Wolfson Medical Center
Key inclusion criteria (3 listed)
- Over 18 years old
- Diagnosed with Sleep Apnea
- DHI score equals or over 16 points
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of Obstructive Sleep Apnea-CPAP/BiPAP etc./Diet/surgery/life style changes | Other | – |
Primary outcome
Dizziness Handicap Inventory Score
Time frame: 3 months
A change in the DHI score after treatment (before treatment and after, 3 months in between)
1 secondary outcome
Romberg on foam test
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Individual participant dataSharing planned: No
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Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Dizziness, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.