Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
TESSA
Inducing Slow Wave Sleep to Treat Obstructive Sleep Apnea
1 other identifier
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
June 6, 2017
CompletedAugust 15, 2017
July 1, 2017
1.3 years
March 9, 2015
May 16, 2017
July 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea Hypopnea Index (AHI)
Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.
1 night
Secondary Outcomes (2)
Slow Wave Sleep (% Total Sleep Time)
1 night
Arousal Threshold (Esophageal Pressure Swing)
1 night
Study Arms (2)
Tiagabine
ACTIVE COMPARATORTiagabine PO 12 mg before sleep
Placebo
PLACEBO COMPARATORPlacebo PO before sleep
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed OSA (moderate-to-severe; apnea hypopnea index \>15 events/hr)
You may not qualify if:
- History of seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Taranto-Montemurro L, Sands SA, Edwards BA, Azarbarzin A, Marques M, de Melo C, Eckert DJ, White DP, Wellman A. Effects of Tiagabine on Slow Wave Sleep and Arousal Threshold in Patients With Obstructive Sleep Apnea. Sleep. 2017 Feb 1;40(2):zsw047. doi: 10.1093/sleep/zsw047.
PMID: 28364504DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Wellman, MD, PhD
- Organization
- Brigham and women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Sleep Disordered Breathing Laboratory
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 13, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
August 15, 2017
Results First Posted
June 6, 2017
Record last verified: 2017-07