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

Sleep Apnea, Obstructive Clinical Trial

— APIGLOSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656160
• Other study ID #: BWH-2014P001033C
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2016
• Last updated: July 15, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy control subjects

Exclusion Criteria:

• Cardiovascular disease other than well controlled hypertension

• History of seizures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Drug:
• Placebo
Placebo 3 hrs before sleep
• Dalfampridine
Dalfampridine 10 mg extended release 3 hrs before sleep

Locations

Country	Name	City	State
United States	Sleep Disorders Research Program Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of dalfampridine on electromyography of genioglossus muscle activity during sleep in control healthy subjects. EMG GG Sleep values will be expressed as %wakefulness value (before drug/placebo administration) and compared between nights.		1 night	No
Secondary	Effect of dalfampridine on genioglossus muscle responsiveness to increased epiglottic pressure swings during sleep in healthy controls. Data will be expressed as change in GG EMG for cmH2O change in epiglottic pressure. (GG%max/cmH2O)		1 night	No
Secondary	Effect of dalfampridine on passive and active collapsibility (Pcrit, cmH2O)		1 night	No