Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | July 2016 |
Inducing Slow Wave Sleep to Treat Obstructive Sleep Apnea
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.
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.
The current study tests the primary hypothesis that tiagabine improves sleep apnea severity
in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine
non-REM sleep; hypopneas defined by 3% desaturation or arousal). The investigators test
three secondary hypotheses that tiagabine:
1. increases the proportion of total sleep time in slow wave sleep
2. raises the non-REM arousal threshold (more negative esophageal pressure) via (1).
3. is preferentially effective in patients whose OSA phenotype predicts that an increase
in the arousal threshold is sufficient to resolve OSA versus those without such
favorable physiology. Favorable physiology is defined here as having a low ventilatory
drive at which stable breathing is theoretically feasible ("stable Vdrive" is <100%
above eupneic ventilatory drive) due to any combination of a "high" upper airway muscle
response, "good" passive anatomy (high Vpassive), and "low" steady-state loop gain (see
Owens RL et al SLEEP 2014; Wellman A et al J Appl Physiol 2011, 2013; Eckert DJ et al
2013 AJRCCM).
in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine
non-REM sleep; hypopneas defined by 3% desaturation or arousal). The investigators test
three secondary hypotheses that tiagabine:
1. increases the proportion of total sleep time in slow wave sleep
2. raises the non-REM arousal threshold (more negative esophageal pressure) via (1).
3. is preferentially effective in patients whose OSA phenotype predicts that an increase
in the arousal threshold is sufficient to resolve OSA versus those without such
favorable physiology. Favorable physiology is defined here as having a low ventilatory
drive at which stable breathing is theoretically feasible ("stable Vdrive" is <100%
above eupneic ventilatory drive) due to any combination of a "high" upper airway muscle
response, "good" passive anatomy (high Vpassive), and "low" steady-state loop gain (see
Owens RL et al SLEEP 2014; Wellman A et al J Appl Physiol 2011, 2013; Eckert DJ et al
2013 AJRCCM).
Inclusion Criteria:
- Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)
Exclusion Criteria:
- History of seizures
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