Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | January 2016 |
| End Date: | October 2016 |
The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects
In this protocol the investigators will test the effect of dalfampridine (a potassium
channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in
healthy control subjects.
channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in
healthy control subjects.
Two overnight sleep studies, a placebo night and a drug night, will be performed
approximately one week apart in random order. The placebo or drug will be administered 3
hours before lights out. At least 10 minutes of quiet wakefulness will be recorded to
quantify the subject's awake EMG GG activity before the administration of
placebo/dalfampridine.
EMG GG activity will be measured again 10 mins before lights off and during stable NREM and
REM sleep (free of arousals and other artifacts).
During the second part of the night, the subjects will be connected to a modified continuous
positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide
range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and
measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).
approximately one week apart in random order. The placebo or drug will be administered 3
hours before lights out. At least 10 minutes of quiet wakefulness will be recorded to
quantify the subject's awake EMG GG activity before the administration of
placebo/dalfampridine.
EMG GG activity will be measured again 10 mins before lights off and during stable NREM and
REM sleep (free of arousals and other artifacts).
During the second part of the night, the subjects will be connected to a modified continuous
positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide
range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and
measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).
Inclusion Criteria:
- Healthy control subjects
Exclusion Criteria:
- Cardiovascular disease other than well controlled hypertension
- History of seizures
We found this trial at
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Boston, Massachusetts 02115
Phone: 617-732-8976
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