Low Blood Pressure, Parkinsons Disease
Conditions
Brief summary
The objective of this experiment is: To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.
Detailed description
Subjects will be asked to sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes. After all inclusion criteria has been met, subjects will then wear an automated BP cuff and be administered 4mg of nicotine gum (Nicorette™). They will be instructed to use it according to manufacturer's directions and remain chewing the gum for 30 minutes. The subject will remain in a seated position and BP and HR will be recorded every 5 minutes for 30 minutes. After 30 minutes the gum will be removed and subjects will still have HR and BP monitored in the seated position for another hour every 10 minutes. All values will be compared to pretreatment values. After 120 minutes if the subject is non-symptomatic, they can go home.
Interventions
DIETARY_SUPPLEMENTNicotine gum
Nicotine chewing gum
Sponsors
New York Institute of Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* a diagnosis of PD * a diastolic BP less than 90 mmHg * and/or a systolic BP lower than 100mHg.
Exclusion criteria
* current tobacco users in all forms of tobacco * severe dysphasia (difficulty swallowing) * previous tobacco users who might be at risk for re-addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure | 90 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Heart Rate | 90 Minutes |
Countries
United States
Outcome results
None listed