# Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep

> **NCT06422364** · NA · TERMINATED · sponsor: **Indiana University** · enrollment: 6 (actual)

## Conditions studied

- Sleep

## Interventions

- **DEVICE:** Weighted Wearable Blanket provided by Dreamland Baby Co.
- **DEVICE:** Weighted Wearable Blanket provided by Dreamland Baby Co.

## Key facts

- **NCT ID:** NCT06422364
- **Lead sponsor:** Indiana University
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2024-04-01
- **Primary completion:** 2024-05-22
- **Final completion:** 2024-05-22
- **Target enrollment:** 6 (ACTUAL)
- **Why stopped:** External to study controversy has arisen around safety of the product. Due to concerns raised by USCPSC and the AAP, the PI has terminated site participation.
- **Last updated:** 2025-06-24

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06422364

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06422364, "Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep". Retrieved via AI Analytics 2026-07-08 from https://api.ai-analytics.org/clinical/NCT06422364. Licensed CC0.

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