Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea (TESSA)
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|ClinicalTrials.gov Identifier: NCT02387710|
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : June 6, 2017
Last Update Posted : August 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Drug: Tiagabine Drug: Placebo||Phase 2|
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:
- increases the proportion of total sleep time in slow wave sleep
- raises the non-REM arousal threshold (more negative esophageal pressure) via (1).
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Inducing Slow Wave Sleep to Treat Obstructive Sleep Apnea|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
Active Comparator: Tiagabine
Tiagabine PO 12 mg before sleep
GABA reuptake inhibitor
Other Name: Gabitril
Placebo Comparator: Placebo
Placebo PO before sleep
- Apnea Hypopnea Index (AHI) [ Time Frame: 1 night ]Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.
- Slow Wave Sleep (% Total Sleep Time) [ Time Frame: 1 night ]Fraction of sleep spent in stage N3
- Arousal Threshold (Esophageal Pressure Swing) [ Time Frame: 1 night ]The arousal threshold was quantified as the mean of all the nadir negative esophageal pressure swings immediately preceding an arousal at the end of an obstructive apnea or hypopnea during both placebo and tiagabine nights.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387710
|United States, Massachusetts|
|Sleep Disorders Research Program Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|