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NCT03816540 · ClinicalTrials.gov registry record · Phase 3
Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia
A Phase 3 study of Hypertension and FXTAS, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03816540: Completed Phase 3 study of Hypertension and FXTAS, sponsored by University of California, Davis.
NCT03816540 is a Phase 3 study of Hypertension and FXTAS that has completed, run by University of California, Davis. The registered enrollment target is 20 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03816540, a Phase 3 study of Hypertension and FXTAS, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Blood pressure is measured at the brachial artery of left arm using an electronic blood pressure monitor with an inflatable cuff, repeated three times at each site, and averaged. Less than 120/80 mmHg is considered "normal," 120/80 to 139/89 mmHg is "prehypertension," and above 140/90 mmHg is "hypertension."
Conditions Studied
Interventions
- DEVICE HRV and respiratory coherence biofeedback
Study Locations (1)
California
- University of California, Davis, MIND Institute - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2019-03-13 |
| Phase | Phase 3 |
What the finished NCT03816540 record still lists
NCT03816540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which HRV and respiratory coherence biofeedback is the first listed.
NCT03816540 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03816540 about?
NCT03816540 is a clinical study titled "Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia". 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 impro...
What is the current status of trial NCT03816540?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2018-05-01. Estimated completion is 2019-03-13.
What conditions does trial NCT03816540 study?
This clinical trial studies the following conditions: Hypertension, FXTAS.
What interventions are being tested in trial NCT03816540?
The interventions under investigation include: HRV and respiratory coherence biofeedback (DEVICE).
Who is sponsoring clinical trial NCT03816540?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03816540 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03816540's enrollment target sits among peer trials
20 438th of 470 higher than 24 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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