Status:
WITHDRAWN
Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
Lead Sponsor:
NYU Langone Health
Conditions:
Bell Palsy
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a randomized, single blinded, non-placebo controlled that will compare one group of Bells Palsy patients receiving the current standard of care including oral corticosteroids and oral antivira...
Eligibility Criteria
Inclusion
- 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.
Exclusion
- No patients from vulnerable populations as listed above will be included.
- Subjects must be able to travel to NYULMC continually during the first 12 months following enrollment.
- During the initial visit candidates must have no associated clinical signs or symptoms consistent with other causes of facial palsy. This includes but is not limited to: auricular papules, skin rashes, parotid masses, craniofacial trauma, and the presence of other cranial or distal neuropathies excluding facial numbness, change in taste, and/or hyperacusis.
- Patients with atypical presentations will be referred for cross-sectional imaging and excluded.
- Patients with histories consistent with possible recent tick exposure, rashes, headaches, or excessive fatigue will be serologically tested for Lyme disease and excluded if it returns positive.
- Pneumothorax within the last two years is the only absolute medical exclusion criteria (FF).
- Patients who are epileptics, or are claustrophobic, will be carefully counseled on the risks of HBOT before being allowed to enroll.
- Patients with severe comorbidities will undergo evaluation by their primary care doctor and require physician approval prior to enrollment.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03457025
Start Date
August 1 2019
End Date
June 1 2020
Last Update
May 29 2020
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016