NCT03457025

Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bell Palsy

Interventions

Type	Name	Description
DRUG	Oral Corticosteroids	Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg
DRUG	Oral antivirals	acyclovir 400mg: one pill 4 times daily for 7 days
DEVICE	Hyperbaric Oxygen Therapy	2.4atm administered for twice daily dives for 5 days, 10 dives total. To be begun in the first 1 week after onset of paralysis.

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-03-07
• Last updated: 2020-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study