Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Apnea, Obstructive
Intervention: Tiagabine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Overall contact: Luigi Taranto Montemurro, MD, Phone: 6177326541, Email: ltarantomontemurro@partners.org
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.
Clinical Details
Official title: Inducing Slow Wave Sleep to Treat Obstructive Sleep Apnea
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: change in apnea hypopnea index (hypopnea criteria: 3% desaturation or arousal)
Secondary outcome: change in slow wave sleep (% total sleep time)increase in arousal threshold (esophageal pressure swing)
Detailed description:
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)
Exclusion Criteria:
- History of seizures
Locations and Contacts
Luigi Taranto Montemurro, MD, Phone: 6177326541, Email: ltarantomontemurro@partners.org
Sleep Disorders Research Program Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting Lauren Hess, RPSGT, Phone: 617-732-8976, Email: lhess1@partners.org
Additional Information
Starting date: March 2015
Last updated: April 21, 2015
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