Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
NCT ID: NCT02656160
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2016-01-31
2016-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Placebo
Placebo
Placebo 3 hrs before sleep
Dalfampridine
Dalfampridine
Dalfampridine 10 mg extended release 3 hrs before sleep
Interventions
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Placebo
Placebo 3 hrs before sleep
Dalfampridine
Dalfampridine 10 mg extended release 3 hrs before sleep
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of seizures
18 Years
70 Years
ALL
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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David Andrew Wellman
Director, Sleep Disordered Breathing Lab, Brigham and Women's Hospital
Locations
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Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Taranto-Montemurro L, Sands SA, Azarbarzin A, Marques M, de Melo CM, Edwards BA, Eckert DJ, Messineo L, White DP, Wellman A. Effect of 4-Aminopyridine on Genioglossus Muscle Activity during Sleep in Healthy Adults. Ann Am Thorac Soc. 2017 Jul;14(7):1177-1183. doi: 10.1513/AnnalsATS.201701-006OC.
Other Identifiers
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BWH-2014P001033C
Identifier Type: -
Identifier Source: org_study_id
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