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lack of enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Therapy | Active Comparator | Reference Therapy |
|
| Standard of Care + HOTB | Experimental | Reference therapy in addition to Hyperbaric Oxygen Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Corticosteroids | Drug | Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group | 3, 6 and 12 months | |
| 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 | 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Markey, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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.
Immediately following publication. No end date.
Only shared with publication.
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| ID | Term |
|---|---|
| D020330 | Bell Palsy |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D000998 | Antiviral Agents |
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
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| Oral antivirals | Drug | acyclovir 400mg: one pill 4 times daily for 7 days |
|
| Hyperbaric Oxygen Therapy | Device | 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. |
|
| 3, 6 and 12 months |
| 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 | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| 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" | 3, 6 and 12 months |
| 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" | 3, 6 and 12 months |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |