Wearable HRV Biofeedback for Stress in Dementia Caregivers

NCT07930364 · tracked via the Priya Life Science Spain tracker

Sponsor

Instituto de Investigación Marqués de Valdecilla

Phase

Not applicable

Started

2026-10-01

Last updated

2026-11-12

Condition(s) studied

Caregiver StressCaregiver BurdenPsychological Stress

Investigational drug(s) / intervention(s)

Heart rate variability biofeedback

Heart rate variability biofeedback: Nurse-delivered behavioral self-regulation training combining individualized resonance-frequency paced breathing with real-time HRV feedback from a low-cost wrist- or chest-worn sensor capable of recording interbeat intervals, paired with a compatible training application. Dose: four supervised sessions of approximately 60 minutes in weeks 1-4, delivered individually or in small groups, followed by supported home practice in weeks 5-8 (target 10 minutes twice daily, or at least 70 accumulated minutes per week), plus one booster contact at month 3. Training frequency is set per participant during an initial paced-breathing assessment across approximately 4.5-6.5 breaths per minute. A brief positive-emotion self-regulation strategy is included. The device model, firmware, and application version are prespecified before recruitment and held constant where possible. Adherence is derived from device and application logs and a participant practice log.

Study summary

This study will evaluate whether a nurse-led heart rate variability (HRV) biofeedback programme supported by a low-cost wearable sensor reduces autonomic dysregulation and perceived stress in informal caregivers of people with dementia. Participants will be prospectively allocated, without randomization, at the day-care-centre level. Before enrolment, the six centres will be characterised according to centre size, estimated number of eligible caregivers and expected recruitment volume, and arranged into three approximately matched pairs. One centre in each pair will implement CARE-COHERENCE and the other will serve as a concurrent comparison centre under a pre-specified operational implementation plan. Follow-up will continue for 12 months.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Adult (18 years or older) self-identified informal, unpaid caregiver of an older person with a clinical diagnosis of dementia attending one of the participating day-care centers. * Providing an average of at least 28 hours of unpaid care per week for a minimum of 3 months. * Able to understand study procedures and provide written informed consent. * Able to use a smartphone and a simple wearable device, independently or with brief study support. Exclusion Criteria: * Persistent or clinically significant cardiac arrhythmia preventing reliable interbeat-interval analysis. * Pacemaker-dependent rhythm or another condition that, in the investigator's judgment, precludes valid heart rate variability assessment. * Current participation in formal heart rate variability biofeedback or structured resonance-frequency breathing training, or equivalent training within the previous 3 months. * Severe uncontrolled psychiatric illness or cognitive impairment precluding informed consent or meaningful participation. * Concurrent enrollment in another structured stress-reduction intervention trial. * Note: use of heart rate-modifying medication, including beta-blockers, is not an exclusion criterion. Medication use is documented prospectively and considered in prespecified sensitivity analyses.

Primary outcome measure(s)

Change in resting RMSSD — Baseline and 6 months
Root mean square of successive differences (RMSSD) derived from a standardised resting interbeat-interval recording obtained with the study wearable sensor and processed according to a prespecified HRV analysis protocol. Higher values indicate greater vagally mediated heart rate variability.

Trial sites (1)

Facility	City	Region	Status
Hospital Universitario Marqués de Valdecilla	Santander	Cantabria	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07930364 on ClinicalTrials.gov ↗ ← All trials in Spain