Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

NYU Langone Health

Status and phase: Withdrawn; Early Phase 1

Conditions: Bell Palsy

Treatments: Drug: Oral antivirals; Device: Hyperbaric Oxygen Therapy; Drug: Oral Corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT03457025

17-01740

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Standard of Care Therapy

Active Comparator group

Description:

Reference Therapy

Treatment:

Drug: Oral antivirals

Drug: Oral Corticosteroids

Standard of Care + HOTB

Experimental group

Description:

Reference therapy in addition to Hyperbaric Oxygen Therapy

Treatment:

Device: Hyperbaric Oxygen Therapy

Drug: Oral antivirals

Drug: Oral Corticosteroids