Clinical trial NCT03457025: Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
Official title: Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Bell Palsy
Keywords: Oxygen Therapy
Bells Palsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 antivirals against an experimental group receiving the current standard of care in addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective analyses of facial movements as well as subjective quality of life scales.


Eligibility criteria: Inclusion Criteria:

* 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group
timeFrame: 3, 6 and 12 months
measure: Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care + Hyperbaric Oxygen Therapy on Bells Palsy (HBOT) Group
timeFrame: 3, 6 and 12 months
Secondary outcomes:
measure: Short Form 36 (SF-36) Score Standard of Care Group
timeFrame: 3, 6 and 12 months
measure: Short Form 36 (SF-36) Score Standard of Care + HBOT
timeFrame: 3, 6 and 12 months
measure: Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group
timeFrame: 3, 6 and 12 months
measure: Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT
timeFrame: 3, 6 and 12 months
measure: Facial Disability Index (FDI) Score Standard of Care Group
timeFrame: 3, 6 and 12 months
measure: Facial Disability Index (FDI) Score Standard of Care + HBOT
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jeffrey Markey, MD
role: PRINCIPAL_INVESTIGATOR
References: