Monitoring System for Cranial Orthoses

NCT06425172 | Recruiting FDA Device

• 1 other identifier: STU-2022-0556
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).

Conditions

Plagiocephaly; Brachycephaly; Deformational Plagiocephaly; Deformational Posterior Plagiocephaly

Outcome Measures

Primary Outcomes (2)

• Wear time monitoring and validation

  The temperature readings from the custom temperature sensor within the research helmet will be compared to the collected temperature readings from the iButtons. Using established software compatible with the iButton, wear time will be calculated based on previously reported temperature thresholds which indicate the helmet is being worn. Using similar temperature thresholds, wear time data from the custom sensors will be compared to the wear time reported by the iButton software.

  Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

• Fit monitoring

  The investigators will examine pressure in the void space of the helmet throughout the 8-9 weeks of wear time. In theory, the pressure in this area should never increase as the cranium should not come in contact with this sensor no matter what position the infant is in (i.e. laying down, sitting, etc).

  Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

Secondary Outcomes (2)

• Survey Participation

  Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year.

• Wear time comparison between objective and subjective reporting

  Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

Study Arms (1)

Infants with with deformational head shapes

Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.

Device: Cranial Remolding Orthosis

Interventions

Cranial Remolding Orthosis DEVICE

A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.

Also known as: Custom Helmet

Infants with with deformational head shapes

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants who are clinically indicated for cranial remolding orthoses.

You may qualify if:

• Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)

You may not qualify if:

• non-English speaking caregivers
• infants with craniosynostosis or those not indicated for cranial remolding
• infants with developmental comorbidities which affect cranial growth

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Plagiocephaly; Craniosynostoses; Plagiocephaly, Nonsynostotic

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases

Study Officials

• Tiffany Graham, MS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Graham, MS

CONTACT

2146458250; Tiffany.Graham@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 22, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)