NCT02656160

Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults

The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	Placebo	Placebo 3 hrs before sleep
DRUG	Dalfampridine	Dalfampridine 10 mg extended release 3 hrs before sleep

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2016-01-14
• Last updated: 2017-08-15
• Results posted: 2017-06-07

Locations

1 site across 1 country: United States