An observational study in Heart Failure, Chronic Heart Failure and Chronic Heart Disease, sponsored by Noah Labs. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Noah Labs · Observational
VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. This study will compare the performance of Noah Labs Vox with the contemporary performance of commonly used weight-based remote monitoring rules and applications to determine efficacy and safety.
VOICE-HF is a prospective, multicenter, single-arm observational study designed to evaluate the performance of the Noah Labs Vox algorithm using an independent test dataset. Noah Labs Vox is intended to detect signs of worsening in patients with heart failure before a Decompensated Heart Failure (DHF) event occurs that would require treatment intensification. To evaluate its technical performance, the VOICE-HF study will recruit approximately 450 participants with Stage C heart failure of any etiology and across the full range of left ventricular ejection fraction (LVEF) to complete daily smartphone based voice recordings for 180 days. The voice data will be collected prospectively via a dedicated mobile smartphone application, and performance will be interpreted in the context of DHF events as adjudicated by a Clinical Events Committee.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 450 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Noah Labs is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible participants will be adult patients (≥22 years) with Stage C heart failure of any etiology and LVEF who experienced a prior decompensated heart failure (DHF) event within 180 days before enrollment.
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Exclusion Criteria:
All participants receive standard heart failure care as per local standard of care, plus daily voice monitoring via a mobile application. Patients record voice samples and answer symptom questions daily. Sites and participants are blinded to the results, which are analyzed retrospectively.
Device: Daily Voice Recording
Patients use the mobile app daily to record voice samples and answer optional wellness and symptom-related questions. Voice recordings are analyzed by an algorithm, which extracts vocal biomechanical features. Results are not shared with clinicians and participants during the study and are analyzed retrospectively after study completion.
Performance Outcome Measure
The co-primary objectives of the study are to evaluate the performance of the Noah Labs Vox algorithm in detecting heart failure decompensation events, in terms of sensitivity and unexplained alert rate.
Time frame: From enrollment to the end of follow up of 6 months
Median Lead Time
The secondary objective of the study is to evaluate how early the Noah Labs Vox algorithm detects heart failure decompensation events, in terms of lead time prior to the event.
Time frame: From enrollment to the end of the follow up period of 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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