Trial · NCT02436031
Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B
NCT02436031, 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 Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B. Trials, record NCT02436031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02436031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B
- NCT number
- NCT02436031
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Sleep Apnea, Obstructive
- Interventions
- Desipramine, Placebo
- First posted
- 2015-05-06
- Last updated
- 2017-03-30
- Results first posted
- 2017-03-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings | 1 night | Electromyography (EMG) was used to analyze genioglossus (GG) \[EMG GG\] muscle activity. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus muscle (tongue). 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). 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 and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness) (%max/cmH2O). |
| Secondary | Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep | 1 night | The AHI is the number of apneas (pauses in breathing) or hypopneas (shallow breathing) recorded during the study per hour of sleep. Data for the calculation of the AHI was collected while the participant was in NREM sleep in the supine position and off CPAP (breathing spontaneously). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. 1 participant was excluded due to insufficient sleep time. | cm H2O | MEDIAN |
| SECONDARY | Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings | 1 night | All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time. | %max/cmH2O | MEDIAN |
| SECONDARY | Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep | 1 night | All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time. | events per hour | 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 |
|---|---|---|---|---|---|
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Desipramine | Active Pcrit | -5.2 | Inter-Quartile Range -7 to -2.8 | cm H2O |
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Placebo | Active Pcrit | -1.9 | Inter-Quartile Range -3.3 to -0.7 | cm H2O |
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Desipramine | Passive Pcrit | -2.2 | Inter-Quartile Range -3.2 to 0.2 | cm H2O |
| Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility | Placebo | Passive Pcrit | -0.7 | Inter-Quartile Range -1.7 to -0.4 | cm H2O |
| Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings | Desipramine | -0.24 | Inter-Quartile Range -0.5 to -0.2 | %max/cmH2O | |
| Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings | Placebo | -0.25 | Inter-Quartile Range -0.4 to -0.1 | %max/cmH2O | |
| Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep | Desipramine | 34.3 | Inter-Quartile Range 14.7 to 62 | events per hour | |
| Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep | Placebo | 42.0 | Inter-Quartile Range 20.5 to 53.3 | events per hour |
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 | 8 | |
| First Study Night | STARTED | Placebo First, Desipramine Second | 8 | |
| First Study Night | COMPLETED | Desipramine First, Placebo Second | 8 | |
| 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 | 7 | |
| Second Study Night | STARTED | Placebo First, Desipramine Second | 8 | |
| Second Study Night | COMPLETED | Desipramine First, Placebo Second | 7 | |
| Second Study Night | COMPLETED | Placebo First, Desipramine Second | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Desipramine | 1 | 16 | |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 15 |
Source ClinicalTrials.gov
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 | 1 | 16 |
| Total, other adverse events | Placebo | 0 | 15 |
| Total, serious adverse events | Desipramine | 0 | 16 |
| Total, serious adverse events | Placebo | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02436031
GET https://conductscience.org/api/trials/v1/NCT02436031/registered