Behavioral Neurocardiac Training and Hypertension

Behavioral Neurocardiac Training With Biofeedback Augments Vagal-Heart Rate Modulation and Baroreflex Sensitivity Among Patients With Hypertension

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00811811

Enrollment

Registered

2008-12-19

Start date

2005-05-31

Completion date

2007-12-31

Last updated

2008-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Biofeedback, Relaxation training

Brief summary

This randomized controlled trial will examine whether behavioral neurocardiac training with heart rate variability biofeedback (BNT) augments reduction in ambulatory daytime and 24-hour SBP, DBP and PP, in comparison to an active control intervention (AC, autogenic relaxation training), among subjects diagnosed with hypertension, and following adjustment for medications. In addition, the independent association between the BNT and AC interventions on vagal-heart rate modulation and baroreflex sensitivity will be evaluated during a standardized assessment protocol of mental stress testing. This study extends a previous trial conducted at the UHN, in which we reported that the biofeedback intervention independently augments vagal-heart rate modulation, while reducing symptoms of stress and depressed mood, among subjects diagnosed with cardiovascular disease. Exploratory features of this trial will examine the association between ambulatory blood pressure, vagal-heart rate modulation, baroreflex sensitivity, and markers of inflammatory activity.

Interventions

BEHAVIORALBehavioral neurocardiac training

6 training sessions scheduled over 8 weeks

BEHAVIORALAutogenic relaxation training

6 training sessions scheduled over 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

35 Years to 64 Years

Healthy volunteers

Inclusion criteria

* 35 to 64 years of age * diagnosis of Grade 1 or 2 hypertension (140-159 mmHg or 160-180 mmHg SBP; or 90-99 or 100-110 mmHg DBP, respectively). * among subjects not prescribed medication, hypertension confirmed by ambulatory BP monitoring: mean 24-hour SBP \> 130 mmHg or DBP \> 80 mmHg. * subjects prescribed antihypertensive pharmacotherapy are required to have a treatment regimen that was unchanged for at least 4 months prior to enrollment.

Exclusion criteria

* diagnosis of cardiovascular disease, clinically significant arrhythmia, sleep disorder, psychiatric illness (eg. psychosis), alcohol/drug dependence within the previous year, or an inability to comprehend English or French

Design outcomes

Primary

Measure	Time frame
Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure.	Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval)

Secondary

Measure	Time frame
RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity	8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026