Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia
Condition: Hypertension; FXTAS
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To study whether heart rate variability training and respiratory coherence can improve
      hypertension in individuals with FXTAS.

      All patients will receive HRV biofeedback training for 20 sessions. Our hypothesis is that
      individuals with FXTAS who undergo 20 sessions of biofeedback training will improve
      self-regulatory skills for reducing hypertension, as measured by blood pressure measurement
      to below 140/90. The investigators hypothesize that individuals who successfully develop
      increased heart rate variability and better synchrony between heart rhythm and respiration
      will show the greatest improvements in self-regulatory skills for hypertension.
    

Detailed description: 
      Fragile X-associated tremor ataxia syndrome (FXTAS) is a late onset neurodegenerative disease
      that affects carriers of the fragile X premutation. This project proposes the evaluation of
      an innovative intervention program that promotes self-regulatory skills for hypertension in
      individuals with FXTAS. Using a control-group experimental design, the investigators propose
      to explore the efficacy of a biofeedback treatment to support self-regulatory processes on
      the physiological level: Heart Rate Variability (HRV) and respiratory coherence biofeedback.

      Chronic hypertension contributes to cardiovascular complications, dementia, and increased
      risk of stroke. Our results indicate that the risk of hypertension is significantly elevated
      in male premutation carriers with FXTAS compared with carriers without FXTAS and controls.

      Several research studies showed high levels of physiological arousal in individuals with
      Fragile X-Associated Disorders (FXS/FX-AD), related to a dysregulation of the sympathetic and
      parasympathetic nervous system. One parameter to measure physiological arousal is
      cardiovascular activity. It provides an index of parasympathetic and sympathetic involvement
      of the autonomic nervous system. Heart rate is under the control of efferent sympathetic and
      vagal activities directed to the sinus node, which are modulated by central brain stem
      (vasomotor and respiratory centers) and peripheral oscillators (oscillation in arterial
      pressure and respiratory movements). Spectral analysis of heart rate variability (HRV) is a
      reliable quantitative method for analyzing the modulatory effects of neural mechanisms on the
      sinus node.

      Biofeedback treatments are reported for over 30 years. Biofeedback provides specific
      information about internal biological processes (i.e. muscle activity, respiration, heart
      rate variability, skin temperature and brain electrical activity) in an individual. In
      general, by enhancing the awareness of these processes and training to volitional control
      over them, specific parameters can be improved. The internal biological processes can be
      measured with a specific biofeedback equipment that convert this data into signals, often in
      the form of auditory, visual or somatosensory events, so that the individual can perceive
      real-time changes in their physiological activity. As the individual learns to control these
      events, healthier physiological processes are conditioned. Depending upon the physiological
      processes targeted, healthier patterns of activity can be achieved by most people after they
      have participated in 10 to 50 sessions of biofeedback supported with professional coaching
      and practice. Various biofeedback protocols and assistive electronic technologies such as the
      NeXus-10, emWave Personal Stress Reliever® or StressEraser® exist to enhance the balance of
      parasympathetic activity, vagal tone, increase HRV and synchronize respiration with the heart
      rhythm (i.e., the slowing down and speeding up of the heart over time).
    

Intervention name(s): HRV and respiratory coherence biofeedback
Intervention type(s): Device
Intervention description(s): Biofeedback treatment to support self-regulatory processes on the physiological level: heart rate variability (HRV) and respiratory coherence.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Same intervention will be applied to FXTAS-affected and unaffected (comparison) participants.
Masking: None (Open Label)
Primary purpose: Treatment