Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults (APIGLOSS)
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|ClinicalTrials.gov Identifier: NCT02656160|
Recruitment Status : Completed
First Posted : January 14, 2016
Results First Posted : June 7, 2017
Last Update Posted : August 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Drug: Placebo Drug: Dalfampridine||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||July 2016|
|Placebo Comparator: Placebo||
Placebo 3 hrs before sleep
|Active Comparator: Dalfampridine||
Dalfampridine 10 mg extended release 3 hrs before sleep
- Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration). [ Time Frame: 1 night ]The EMG GG was quantified in arbitrary units derived from signal processing of the raw signal and as a percentage of wakefulness (%wake) for between-nights comparison of baseline sleep EMG GG activity. EMG GG analysis was performed on a breath-by-breath basis to identify a maximum value and a minimum value during inspiration and expiration, respectively (EMG GG peak and tonic). The difference between peak and tonic values was used to estimate respiratory related phasic activity. Wakefulness EMG GG values were obtained from a minimum of 10 epochs (30 s each) with the subject lying in the lateral position. Criteria for breath selection during wakefulness were (1) stable breathing (constant epiglottic pressure swings) and (2) absence of movement artifacts (i.e., swallowing, speech, yawns).
- Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O) [ Time Frame: 1 night ]Effect of dalfampridine on genioglossus muscle responsiveness to increased epiglottic pressure swings during sleep in healthy controls during NREM sleep. The variation of EMG GG is expressed here as % of maximal activation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656160
|United States, Massachusetts|
|Sleep Disorders Research Program Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|