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Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

NCT03457025 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-05-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Markey, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457025 on ClinicalTrials.gov