Wearable HRV Biofeedback for Stress in Dementia Caregivers
NCT07930364, Not applicable, Recruiting, Instituto de Investigación Marqués de Valdecilla
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Wearable HRV Biofeedback for Stress in Dementia Caregivers | ClinicalTrials.gov |
| NCT number | NCT07930364 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Instituto de Investigación Marqués de Valdecilla | ClinicalTrials.gov |
| Conditions | Caregiver Stress, Caregiver Burden, Psychological Stress | ClinicalTrials.gov |
| Interventions | Heart rate variability biofeedback | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Secondary | Change in perceived stress (Perceived Stress Scale, PSS-10) | Baseline, 8 weeks, 6 months and 12 months | Perceived stress measured with the 10-item Perceived Stress Scale (PSS-10). Total score ranges from 0 to 40. Higher scores indicate greater perceived stress; a decrease indicates improvement. Analyzed as change from baseline and as the follow-up value adjusted for the baseline score. This is the key secondary outcome. | ClinicalTrials.gov |
| Secondary | Maintenance of resting RMSSD at 12 months | Baseline and 12 months | Root mean square of successive differences (RMSSD, in milliseconds) derived from a standardized resting interbeat-interval recording obtained with the study wearable sensor and processed with the prespecified HRV analysis pipeline. Higher values indicate greater vagally mediated heart rate variability. Assesses whether any intervention effect on the primary outcome is maintained six months after the primary endpoint. | ClinicalTrials.gov |
| Secondary | Change in caregiver burden (Zarit Burden Interview, ZBI-22) | Baseline, 8 weeks, 6 months and 12 months | Caregiver burden measured with the 22-item Zarit Burden Interview. Total score ranges from 0 to 88. Higher scores indicate greater burden; a decrease indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in resting SDNN | Baseline, 8 weeks, 6 months and 12 months | Standard deviation of normal-to-normal interbeat intervals (SDNN, in milliseconds) from the same standardized resting recording used for the primary outcome. Higher values indicate greater overall heart rate variability. | ClinicalTrials.gov |
| Secondary | Change in mean resting heart rate | Baseline, 8 weeks, 6 months and 12 months | Mean heart rate in beats per minute derived from the standardized resting interbeat-interval recording. | ClinicalTrials.gov |
| Secondary | Change in well-being (WHO-5 Well-Being Index) | Baseline, 8 weeks, 6 months and 12 months | Well-being measured with the five-item WHO-5 Well-Being Index. The raw score ranges from 0 to 25 and is multiplied by 4 to give a percentage score from 0 to 100. Higher scores indicate better well-being; an increase indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in anxiety and depressive symptoms (Hospital Anxiety and Depression Scale, HADS) | Baseline, 8 weeks, 6 months and 12 months | Symptoms measured with the Hospital Anxiety and Depression Scale. The HADS-Anxiety and HADS-Depression subscales are reported separately; each ranges from 0 to 21. Higher scores indicate more severe symptoms; a decrease indicates improvement. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 25796509 | BACKGROUND | PubMed |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.