CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
HRV and respiratory coherence biofeedbackdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03816540
NCT03816540Phase 3Completed

Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia

University of California, Davis·interventional·Posted Jan 25, 2019·Updated Oct 22, 2019

In Brief

A Phase 3 clinical trial evaluating HRV and respiratory coherence biofeedback for Hypertension and FXTAS. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, FXTAS
CountriesUnited States

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 25, 2019
Enrollment StartMay 1, 2018
Primary CompletionMar 13, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.4 years ago

Interventions

HRV and respiratory coherence biofeedbackdevice

Biofeedback treatment to support self-regulatory processes on the physiological level: heart rate variability (HRV) and respiratory coherence.