Phase 2
Completed N=17
Effect of Desipramine on Genioglossus Muscle Activity in Healthy Adults Study A
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT02428478 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity — 96; 75; 84; 93 percent wakefulness — p=0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity |
96; 75; 84; 93 | 0.01 sig |
| SECONDARY Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility |
-10.0; -8.1; -14.9; -10.5 | 0.037 sig |
Eligibility Criteria
Inclusion Criteria
- Healthy control subjects
Exclusion Criteria
- Cardiovascular disease other than well controlled hypertension
- Depression
Data sourced from ClinicalTrials.gov (NCT02428478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.