Phase 2
N=18
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02387710 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Apnea Hypopnea Index (AHI) — 39.1; 40.8 events/hour — p=>0.5
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tiagabine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI) |
39.1; 40.8 | >0.5 |
| SECONDARY Slow Wave Sleep (% Total Sleep Time) |
8.3; 8.8 | — |
| SECONDARY Arousal Threshold (Esophageal Pressure Swing) |
-27.6; -26.5 | — |
Summary
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse from sleep. Here the investigators test the idea that the medication called "tiagabine" improves slow wave sleep and reduces OSA severity. The investigators will also test whether tiagabine raises the arousal threshold (more negative esophageal pressure), and whether detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with this intervention.
Eligibility Criteria
Inclusion Criteria
- Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)
Exclusion Criteria
- History of seizures
Data sourced from ClinicalTrials.gov (NCT02387710). 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.