Back to resultsEffect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
Primary Purpose
Bell Palsy
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral Corticosteroids
Oral antivirals
Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bell Palsy focused on measuring Oxygen Therapy, Bells Palsy
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care Therapy
Standard of Care + HOTB
Arm Description
Reference Therapy
Reference therapy in addition to Hyperbaric Oxygen Therapy
Outcomes
Primary Outcome Measures
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group
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
Secondary Outcome Measures
Short Form 36 (SF-36) Score Standard of Care Group
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Short Form 36 (SF-36) Score Standard of Care + HBOT
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group
Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT
Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.
Facial Disability Index (FDI) Score Standard of Care Group
Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"
Facial Disability Index (FDI) Score Standard of Care + HBOT
Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03457025
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
lack of enrollment
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Oxygen Therapy, Bells Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Therapy
Arm Type
Active Comparator
Arm Description
Reference Therapy
Arm Title
Standard of Care + HOTB
Arm Type
Experimental
Arm Description
Reference therapy in addition to Hyperbaric Oxygen Therapy
Intervention Type
Drug
Intervention Name(s)
Oral Corticosteroids
Intervention Description
Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg
Intervention Type
Drug
Intervention Name(s)
Oral antivirals
Intervention Description
acyclovir 400mg: one pill 4 times daily for 7 days
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group
Time Frame
3, 6 and 12 months
Title
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
Time Frame
3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Short Form 36 (SF-36) Score Standard of Care Group
Description
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Time Frame
3, 6 and 12 months
Title
Short Form 36 (SF-36) Score Standard of Care + HBOT
Description
As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Time Frame
3, 6 and 12 months
Title
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group
Description
Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.
Time Frame
3, 6 and 12 months
Title
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT
Description
Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.
Time Frame
3, 6 and 12 months
Title
Facial Disability Index (FDI) Score Standard of Care Group
Description
Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"
Time Frame
3, 6 and 12 months
Title
Facial Disability Index (FDI) Score Standard of Care + HBOT
Description
Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"
Time Frame
3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Markey, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Only as pertains to study results, will be shared only during publication.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Only shared with publication.
Learn more about this trial
Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
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