Trial · NCT02428478
Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A
NCT02428478, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2017-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A. Trials, record NCT02428478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02428478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A
- NCT number
- NCT02428478
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Sleep Apnea, Obstructive
- Interventions
- Desipramine, Placebo
- First posted
- 2015-04-28
- Last updated
- 2017-03-30
- Results first posted
- 2017-03-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity | 1 night | 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. |
| Secondary | Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | 1 night | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity | 1 night | 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. | percent wakefulness | MEDIAN |
| SECONDARY | Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | 1 night | 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. | cm H2O | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity | Desipramine | Tonic | 96 | Inter-Quartile Range 86 to 120 | percent wakefulness |
| Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity | Placebo | Tonic | 75 | Inter-Quartile Range 50 to 92 | percent wakefulness |
| Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity | Desipramine | Phasic | 84 | Inter-Quartile Range 49 to 90 | percent wakefulness |
| Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity | Placebo | Phasic | 93 | Inter-Quartile Range 74 to 106 | percent wakefulness |
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Desipramine | Passive Pcrit | -10.0 | Inter-Quartile Range -15.2 to -5.8 | cm H2O |
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Placebo | Passive Pcrit | -8.1 | Inter-Quartile Range -10.4 to -6.3 | cm H2O |
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Desipramine | Active Pcrit | -14.9 | Inter-Quartile Range -18.5 to -6.8 | cm H2O |
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Placebo | Active Pcrit | -10.5 | Inter-Quartile Range -15.6 to -8.6 | cm H2O |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Study Night | STARTED | Desipramine First, Placebo Second | 9 | |
| First Study Night | STARTED | Placebo First, Desipramine Second | 8 | |
| First Study Night | COMPLETED | Desipramine First, Placebo Second | 9 | |
| First Study Night | COMPLETED | Placebo First, Desipramine Second | 8 | |
| First Study Night | NOT COMPLETED | Desipramine First, Placebo Second | 0 | |
| First Study Night | NOT COMPLETED | Placebo First, Desipramine Second | 0 | |
| Second Study Night | STARTED | Desipramine First, Placebo Second | 8 | |
| Second Study Night | STARTED | Placebo First, Desipramine Second | 6 | |
| Second Study Night | COMPLETED | Desipramine First, Placebo Second | 8 | |
| Second Study Night | COMPLETED | Placebo First, Desipramine Second | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Desipramine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Desipramine | 0 | 15 |
| Total, other adverse events | Placebo | 0 | 16 |
| Total, serious adverse events | Desipramine | 0 | 15 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26967681 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Desipramine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02428478
GET https://conductscience.org/api/trials/v1/NCT02428478/registered