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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
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE January 12, 2016
First Posted Date  ICMJE January 14, 2016
Results First Submitted Date  ICMJE March 29, 2017
Results First Posted Date  ICMJE June 7, 2017
Last Update Posted Date August 15, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
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. [ Time Frame: 1 night ]
Change History Complete list of historical versions of study NCT02656160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Effect of dalfampridine on genioglossus muscle responsiveness to incresed 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) [ Time Frame: 1 night ]
  • Effect of dalfampridine on passive and active collapsibility (Pcrit, cmH2O) [ Time Frame: 1 night ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
Official Title  ICMJE The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sleep Apnea, Obstructive
Intervention  ICMJE
  • Drug: Placebo
    Placebo 3 hrs before sleep
  • Drug: Dalfampridine
    Dalfampridine 10 mg extended release 3 hrs before sleep
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Dalfampridine
    Intervention: Drug: Dalfampridine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2016)
13
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
15
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy control subjects

Exclusion Criteria:

  • Cardiovascular disease other than well controlled hypertension
  • History of seizures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656160
Other Study ID Numbers  ICMJE BWH-2014P001033C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Andrew Wellman, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP