Trial Outcomes & Findings for Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A (NCT NCT02428478)
NCT ID: NCT02428478
Last Updated: 2017-03-30
Results Overview
Electromyography (EMG) was used to analyze genioglossus (GG) \[EMG GG\] muscle movement. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus (tongue) muscle. Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Sleep values were then expressed as %wakefulness value for tonic and phasic EMG GG activity. Tonic activity was defined as the lowest EMG GG value during expiration, phasic activity was calculated as the peak value during inspiration minus the tonic value.
COMPLETED
PHASE2
17 participants
1 night
2017-03-30
Participant Flow
Participant milestones
| Measure |
Desipramine First, Placebo Second
Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
|
Placebo First, Desipramine Second
Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
|
|---|---|---|
|
First Study Night
STARTED
|
9
|
8
|
|
First Study Night
COMPLETED
|
9
|
8
|
|
First Study Night
NOT COMPLETED
|
0
|
0
|
|
Second Study Night
STARTED
|
8
|
6
|
|
Second Study Night
COMPLETED
|
8
|
6
|
|
Second Study Night
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A
Baseline characteristics by cohort
| Measure |
All Analyzed Participants
n=10 Participants
All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.
|
|---|---|
|
Age, Continuous
|
27.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 nightPopulation: All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.
Electromyography (EMG) was used to analyze genioglossus (GG) \[EMG GG\] muscle movement. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus (tongue) muscle. Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Sleep values were then expressed as %wakefulness value for tonic and phasic EMG GG activity. Tonic activity was defined as the lowest EMG GG value during expiration, phasic activity was calculated as the peak value during inspiration minus the tonic value.
Outcome measures
| Measure |
Desipramine
n=10 Participants
Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
|
Placebo
n=10 Participants
Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
|
|---|---|---|
|
Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity
Tonic
|
96 percent wakefulness
Interval 86.0 to 120.0
|
75 percent wakefulness
Interval 50.0 to 92.0
|
|
Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity
Phasic
|
84 percent wakefulness
Interval 49.0 to 90.0
|
93 percent wakefulness
Interval 74.0 to 106.0
|
SECONDARY outcome
Timeframe: 1 nightPopulation: All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.
Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are passive; Active Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are active. Improved=more negative Pcrit.
Outcome measures
| Measure |
Desipramine
n=10 Participants
Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
|
Placebo
n=10 Participants
Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
|
|---|---|---|
|
Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility
Passive Pcrit
|
-10.0 cm H2O
Interval -15.2 to -5.8
|
-8.1 cm H2O
Interval -10.4 to -6.3
|
|
Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility
Active Pcrit
|
-14.9 cm H2O
Interval -18.5 to -6.8
|
-10.5 cm H2O
Interval -15.6 to -8.6
|
Adverse Events
Desipramine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place