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NCT02428478 · ClinicalTrials.gov registry record · Phase 2
Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02428478: Completed Phase 2 study, sponsored by Brigham and Women's Hospital.
NCT02428478 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02428478, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on genioglossus muscle activity (EMG GG) during sleep in healthy control participants.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Desipramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT02428478 record still lists
NCT02428478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02428478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02428478 about?
NCT02428478 is a clinical study titled "Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A". Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. U...
What is the current status of trial NCT02428478?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-03. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02428478?
The interventions under investigation include: Placebo (DRUG), Desipramine (DRUG).
Who is sponsoring clinical trial NCT02428478?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02428478's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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