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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02656160
Recruitment Status : Completed
First Posted : January 14, 2016
Results First Posted : June 7, 2017
Last Update Posted : August 15, 2017
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Drug: Placebo Drug: Dalfampridine Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo 3 hrs before sleep

Active Comparator: Dalfampridine Drug: Dalfampridine
Dalfampridine 10 mg extended release 3 hrs before sleep

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy control subjects

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02656160

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United States, Massachusetts
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Andrew Wellman, Director, Sleep Disordered Breathing Lab, Brigham and Women's Hospital, Brigham and Women's Hospital Identifier: NCT02656160    
Other Study ID Numbers: BWH-2014P001033C
First Posted: January 14, 2016    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: August 15, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action