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NCT06131463
Anxiety Associated With the Use of the Electrocardiogram Function in Smart Watches
NA trial testing Electrocardiogram (ECG) feature in smart watches in Mental Health Wellness 1 in 71 participants. Completed in 4 March 2024.
16 January 2024
Quick facts
| Lead sponsor | ITMO University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 71 |
| Start date | 13 November 2023 |
| Primary completion | 16 January 2024 |
| Estimated completion | 4 March 2024 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Electrocardiogram (ECG) feature in smart watches
Conditions studied
- Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →
- Anxiety Disorders — all drugs for Anxiety Disorders →
- Depression — all drugs for Depression →
Sponsor
ITMO University
Who can join
Adults 22 to 100, any sex, with Mental Health Wellness 1 or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The integration of electrocardiography (ECG) functionality into smartwatches is primarily intended to screen for atrial fibrillation, a frequent cause of ischemic stroke, among people aged 50 years and older. However, it should be noted that recommendations for atrial fibrillation screening are controversial, and several organizations and communities do not recommend screening outside of at-risk groups. Some smart device manufacturers do not recommend using the ECG function for anyone under the age of 22. However, young people are frequent users of wearable devices. One of the most common cardiologic diseases at the age of 18-30 is benign heart rhythm disorder, which often does not require diagnosis or treatment and can be considered normal. That said, notification of the detection of atrial fibrillation can affect psycho-emotional well-being, particularly anxiety. This study will assess the level of psycho-emotional health (anxiety level) of the study participants. Participant observation will provide an opportunity to identify associations between the use of the ECG recording function on wearable devices and levels of anxiety and depression. It is hypothesized that the use of smartwatches with the ECG function activated will not lead to a change in anxiety levels on the GAD-7 scale among the study participants. This assumes that after 30 days of use, the mean value of the GAD-7 scale in the intervention group and the control group will be the same.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06131463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other ITMO University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06131463 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ITMO University
- Last refreshed: 4 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06131463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing