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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: Dalfampridine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02656160

BWH-2014P001033C

Details and patient eligibility

About

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.

Full 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).

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy control subjects

Exclusion criteria

• Cardiovascular disease other than well controlled hypertension
• History of seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

13 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Dalfampridine

Active Comparator group

Treatment:

Drug: Dalfampridine