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NCT06659978: NICU-TAC
Human Factors Validation and Acceptability Testing of a Stimulation Device
trial testing Device tolerance in Human Factors in 34 participants. Completed in 2 February 2025.
30 April 2024
Quick facts
| Lead sponsor | University of Liverpool |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 34 |
| Start date | 5 January 2024 |
| Primary completion | 30 April 2024 |
| Estimated completion | 2 February 2025 |
| Sites | 3 locations across United Kingdom |
Drugs / interventions tested
- Device tolerance
- Acceptability questionnaire
Conditions studied
- Human Factors — all drugs for Human Factors →
- Acceptability — all drugs for Acceptability →
- Tolerance — all drugs for Tolerance →
Sponsor
University of Liverpool
Who can join
Adults 34 Weeks to 42 Weeks, any sex, with Human Factors or Acceptability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Our team have developed a mattress topper, consisting of rubber tubes attached side to side that are deflated and inflated, mimicking dynamic touch and optimal CT stimulation (3cm/s). It is connected to a microprocessor control unit and a vacuum supply. By controlling the interval between the vacuum applied to each tube in the device it generates a flow sequence as each tube relaxes back to its original state. This will feel like a stroking across the skin - but non-frictional, thereby minimising the risk of friction related skin damage. The device is placed on top of a standard mattress in a neonatal cot. It has been manufactured in line with European Union (EU) safety requirements. It has been calibrated to mimic optimal CT fibre activation at 3cm/s, in line with previous touch intervention studies (Gursul et al., 2018; Manzotti et al., 2019). The device is made from silicone and is fully waterproof. A cleaning protocol will be implemented between each use for infection control. The waterproof sheet will be covered by a standard cot sheet.
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 NCT06659978
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06659978 (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 University of Liverpool
- Last refreshed: 22 April 2025
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/NCT06659978.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing