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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 2, 1999 | ||||
| Last Updated Date | August 5, 2008 | ||||
| Start Date ICMJE | October 1998 | ||||
| Primary Completion Date | June 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Vertigo [ Time Frame: 6 month s ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00000359 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Balance [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatments for Benign Paroxysmal Positional Vertigo (BPPV) | ||||
| Official Title ICMJE | Treatments for Benign Paroxysmal Positional Vertigo (BPPV) | ||||
| Brief Summary | The purpose of this study is to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the Epley maneuver, the Semont maneuver, the Brandt-Daroff exercises and nonspecific vestibular habituation exercises. These procedures involve exercises and head manipulations. Vertigo intensity and frequency, the presence/absence of slow-phase eye movements, the degree of dizziness handicap and acts of daily living (ADL) shall be assessed. The study will also ascertain the effects of co-morbid conditions on the response to treatment. While BPPV is a common and significant public health problem that has been recognized for several decades, this is the first systematic study of the relative treatment efficacy of different physical treatment modalities for this disorder. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Efficacy Study | ||||
| Condition ICMJE | Vertigo | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 149 | ||||
| Completion Date | June 2003 | ||||
| Primary Completion Date | June 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients may be eligible for this study if they:
Exclusion Criteria: Patients will not be eligible for this study if they:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00000359 | ||||
| Responsible Party | Helen Cohen, EdD, Baylor College of Medicine | ||||
| Study ID Numbers ICMJE | NIDCD-1156, 1 R01 DC03602-01A1 | ||||
| Study Sponsor ICMJE | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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