Anosmia, Head Trauma
Conditions
Brief summary
This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the treatment of olfactory loss due to head injury. The hypothesis is that treatment with NAC acutely after head injury will result in improved olfactory function
Interventions
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
DRUGPlacebo oral capsule
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to Ryder Trauma Center for observation acutely following head injury (i.e. concussion), with documented hyposmia or anosmia by University of Pennsylvania Smell Identification Test (SIT). * Male or female, aged 18 years or older * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Ability to take oral medication and be willing to adhere to the NAC regimen * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of NAC administration
Exclusion criteria
* Severe trauma requiring ongoing inpatient treatment beyond 48 hours * Pregnancy (based on urine screening) or lactation * Known allergic reactions to components of NAC, such as Mucomyst * Currently taking nitrates such as nitroglycerine and/or isosorbide regularly * Currently taking azathioprine (Imuran) or cyclophosphamide (Cytoxan) * Known diagnosis of cystinuria (renal condition in which cysteine supplement should be avoided) * Febrile illness within 1 week * Treatment with another investigational drug or other intervention within 3 months * Active sinonasal disease by imaging and/or nasal exam, i.e. rhinosinusitis, nasal polyps * Adults unable to consent * Prisoners, employees or subordinates * Individuals who are not yet adults (infants, children, teenagers). This population is excluded because efficacy has not yet been established in adults.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olfactory Function | 4 months | Olfactory function will be measured using the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The total score ranges from 0-40 with the higher score indicating better olfactory function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire | 4 months | Quality of life will be measured using the questionnaire for Olfactory Disorders (QOD). QOD has a total score from 0-75 with the higher score indicating a better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAC Group NAC group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days | 3 |
| Placebo Group Placebo group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| At Home Treatment | Lost to Follow-up | 0 | 1 |
| At Home Treatment | Study Termination | 3 | 0 |
| At Home Treatment | Withdrawal by Subject | 0 | 2 |
| Visit 3 (4 Month Follow up) | Study Termination | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo Group | Total | NAC Group |
|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 15.8 | 41.7 years STANDARD_DEVIATION 14.5 | 48.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Olfactory Function
Olfactory function will be measured using the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The total score ranges from 0-40 with the higher score indicating better olfactory function.
Time frame: 4 months
Population: Data will not be reported due to confidentiality, there was only one participant to complete the 1 month follow up visit. Study was terminated prior to the remaining participants completing any follow up visits as per protocol.
Secondary
Quality of Life Questionnaire
Quality of life will be measured using the questionnaire for Olfactory Disorders (QOD). QOD has a total score from 0-75 with the higher score indicating a better quality of life.
Time frame: 4 months
Population: Data will not be reported due to confidentiality, there was only one participant to complete the 1 month follow up visit. Study was terminated prior to the remaining participants completing any follow up visits as per protocol.