Phase 2
Completed N=16
Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT02436031 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility — -5.2; -1.9; -2.2; -0.7 cm H2O — p=0.049
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 upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility |
-5.2; -1.9; -2.2; -0.7 | 0.049 sig |
| SECONDARY Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings |
-0.24; -0.25 | — |
| SECONDARY Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep |
34.3; 42.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)
Exclusion Criteria
- Cardiovascular disease other than well controlled hypertension
- Depression
Data sourced from ClinicalTrials.gov (NCT02436031). 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.