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Trial record 5 of 47 for:    DESIPRAMINE

Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A (DESOSA)

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ClinicalTrials.gov Identifier: NCT02428478
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Sleep Apnea, Obstructive
Interventions Drug: Desipramine
Drug: Placebo
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desipramine First, Placebo Second Placebo First, Desipramine Second
Hide Arm/Group Description 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-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.
Period Title: First Study Night
Started 9 8
Completed 9 8
Not Completed 0 0
Period Title: Second Study Night
Started 8 [1] 6 [2]
Completed 8 6
Not Completed 0 0
[1]
1 participant did not return for the second study night
[2]
2 participants did not return for the second study night
Arm/Group Title All Analyzed Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants
27.5
(24.0 to 39.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
1.Primary Outcome
Title Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity
Hide Description 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.
Time Frame 1 night
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desipramine Placebo
Hide Arm/Group Description:
Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: percent wakefulness
Tonic
96
(86 to 120)
75
(50 to 92)
Phasic
84
(49 to 90)
93
(74 to 106)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desipramine, Placebo
Comments Tonic analysis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments P<0.05 considered statistically significant
Method Wilcoxon Matched-Pairs Signed-Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desipramine, Placebo
Comments Phasic analysis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments P<0.05 considered statistically significant
Method Wilcoxon Matched-Pairs Signed-Rank Test
Comments [Not Specified]
2.Secondary Outcome
Title Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility
Hide Description 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.
Time Frame 1 night
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Desipramine Placebo
Hide Arm/Group Description:
Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: cm H2O
Passive Pcrit
-10.0
(-15.2 to -5.8)
-8.1
(-10.4 to -6.3)
Active Pcrit
-14.9
(-18.5 to -6.8)
-10.5
(-15.6 to -8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desipramine, Placebo
Comments Passive Pcrit
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Wilcoxon Matched-Pairs Signed-Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Change
Estimated Value -0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desipramine, Placebo
Comments Active Pcrit
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.5
Comments [Not Specified]
Method Wilcoxon Matched-Pairs Signed-Rank Test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least one dose of desipramine or placebo.
 
Arm/Group Title Desipramine Placebo
Hide Arm/Group Description Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night. Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
All-Cause Mortality
Desipramine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Desipramine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desipramine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Wellman, MD, PhD
Organization: Brigham and Women's Hospital
EMail: awellman@rics.bwh.harvard.edu
Layout table for additonal information
Responsible Party: David Andrew Wellman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02428478     History of Changes
Other Study ID Numbers: BWH-2014P001033A
First Submitted: April 21, 2015
First Posted: April 28, 2015
Results First Submitted: February 11, 2017
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017