An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0

Skin Injury Clinical Trial

Official title: An Observational Study of Skin Reaction in Infants Using the Owlet Sock OSS 3.0

Status Completed

Clinical Trial Summary

This multi-center, open-label, observational study will evaluate possible skin reactions associated with the wearing of the Owlet OSS 3.0 device continuously (except during sensor charging and excessive motion) up to 24 hours per day in a clinical environment.

Clinical Trial Description

After an informed consent process, the Owlet OSS 3.0 Sock device will be applied to the foot in accordance with the instructions for use for the device. A research team member, along with any appropriate medical personnel, will perform a baseline examination of the skin to ensure there are no preexisting skin or extremity findings which would interfere with interpretation of subsequent examinations.

A review of the medical record will be performed with the consent process to ensure that vital signs and the cardiorespiratory status of the patient is sufficiently stable for the patient to proceed with study participation. A verbal medical history from the parent may be performed in lieu of a medical record review in healthy subjects.

Subject height and weight, and measurements of the circumference of the subject's ankle and midfoot will be performed at the start of the study and recorded. Sock size will be estimated according to subject weight, per the instructions for use.

The device will be worn by the subject continuously, except during skin assessments, when devices are exchanged, or activities of daily living such as bathing and brief ambulation for toddlers.

A baseline photograph will be taken of the study subject's feet and labeled as right/left, to be kept for reference for future skin exams. Skin examinations will be performed every 4 hours on the foot where the device is placed, including with repositioning. A ±30-minute window on either side of the prescribed time will be acceptable (1 hour total) to comply with the schedule of events.

Repositioning the device to the opposite foot will occur routinely every 8 hours, or sooner if there is evidence of a skin reaction related to device wear. Again, a ±30-minute window on either side of the prescribed time will be acceptable for protocol compliance.

A photograph will be taken of the study subject's feet at baseline prior to application of the Owlet Sock OSS 3.0 device. A photograph of the initial application of the device will also be taken and documented in the study subject's record.

Documentation of the date, time, location, and result of each skin exam will be performed. Photographs of any skin reactions with a severity level of 1-7 will be taken. If any skin reactions are observed, the device will not be placed on the affected foot until the reaction has resolved and returned to baseline. The device will be applied to the unaffected foot while the affected foot reaction resolves. If the skin finding does not resolve within the allowed 8 hour window when the sock must be rotated to the opposite foot, the subject will be withdrawn from study intervention. ;

Related Conditions & MeSH terms

• Skin Injury

• NCT number: NCT05561946
• Study type: Observational
• Source: Owlet Baby Care, Inc.
• Status: Completed
• Start date: December 21, 2021
• Completion date: August 24, 2022