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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
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Drug: Tiagabine Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Tiagabine
Tiagabine PO 12 mg before sleep
Drug: Tiagabine
GABA reuptake inhibitor
Other Name: Gabitril

Placebo Comparator: Placebo
Placebo PO before sleep
Drug: Placebo
Placebo comparator




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Slow Wave Sleep (% Total Sleep Time) [ Time Frame: 1 night ]
    Fraction of sleep spent in stage N3

  2. 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.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr)

Exclusion Criteria:

  • History of seizures

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Andrew Wellman, Director, Sleep Disordered Breathing Laboratory, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02387710     History of Changes
Other Study ID Numbers: BWH-2012P000956B
First Posted: March 13, 2015    Key Record Dates
Results First Posted: June 6, 2017
Last Update Posted: August 15, 2017
Last Verified: July 2017

Keywords provided by David Andrew Wellman, Brigham and Women's Hospital:
arousal threshold
phenotype
tiagabine
slow wave sleep

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Tiagabine
Anticonvulsants
GABA Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs