Bell PalsyEarly Phase 1NCT03457025
Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
A Early Phase 1 study testing Oral Corticosteroids, Oral antivirals and Hyperbaric Oxygen Therapy in people with Bell Palsy, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Oral Corticosteroids, Oral antivirals and Hyperbaric Oxygen Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2019to Jun 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Oral Corticosteroids, Oral antivirals, Hyperbaric Oxygen Therapy
- Keywords
- Oxygen Therapy, Bells Palsy
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CorticosteroidsDrug
Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg
Oral antiviralsDrug
acyclovir 400mg: one pill 4 times daily for 7 days
Hyperbaric Oxygen TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Therapy | Active comparator | Reference Therapy Receives: Drug: Oral Corticosteroids; Drug: Oral antivirals |
| Standard of Care + HOTB | Experimental | Reference therapy in addition to Hyperbaric Oxygen Therapy Receives: Drug: Oral Corticosteroids; Drug: Oral antivirals; Device: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group
Measured: 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
Measured: 3, 6 and 12 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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"
Measured: 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"
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study startAug 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Markey, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457025
- Sponsor's protocol ID
- 17-01740
- Status last verified
- May 2020
- First submitted
- 31 Jan 2018
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
- ClinicalTrials.gov ID
- NCT03457025
- Acronym / sponsor ID
- 17-01740
- Conditions
- Bell Palsy
- Keywords
- Oxygen Therapy, Bells Palsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Therapy | Active comparator | Drug: Oral Corticosteroids, Drug: Oral antiviralsReference Therapy |
| Standard of Care + HOTB | Experimental | Drug: Oral Corticosteroids, Drug: Oral antivirals, Device: Hyperbaric Oxygen TherapyReference therapy in addition to Hyperbaric Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral CorticosteroidsPrednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg | Drug | Standard of Care + HOTB, Standard of Care Therapy |
| Oral antiviralsacyclovir 400mg: one pill 4 times daily for 7 days | Drug | Standard of Care + HOTB, Standard of Care Therapy |
| Hyperbaric Oxygen Therapy2.4atm administered for twice daily dives for 5 days, 10 dives total. To be begun in the first 1 week after onset of paralysis. | Device | Standard of Care + HOTB |
Primary outcome
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
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
6 secondary outcomes
Short Form 36 (SF-36) Score Standard of Care Group
Time frame: 3, 6 and 12 months
Short Form 36 (SF-36) Score Standard of Care + HBOT
Time frame: 3, 6 and 12 months
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group
Time frame: 3, 6 and 12 months
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT
Time frame: 3, 6 and 12 months
Facial Disability Index (FDI) Score Standard of Care Group
Time frame: 3, 6 and 12 months
Facial Disability Index (FDI) Score Standard of Care + HBOT
Time frame: 3, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Markey, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral Corticosteroids, Oral antivirals and Hyperbaric Oxygen Therapy in people with Bell Palsy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.