Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile

NACompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

October 31, 2023

Study Completion Date

December 10, 2023

Conditions
OsteopeniaLow Bone Density
Interventions
DEVICE

Spry Belt

The Spry Belt is a device worn around the hips which delivers gentle energy to the lower back. The level of energy is controlled by an internal microprocessor (computer) so that it is safe and comfortable. The energy is at a level that may or may not be perceptible to the user. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via Bluetooth Low Energy (BLE)) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months.

DEVICE

Sham Spry Belt

The Sham Spry Belt is a device worn around the hips which does not deliver gentle energy to the lower back. The device instead provides a clicking noise similar to a motor. The device is powered by an internal lithium-ion battery which must be recharged periodically. The device is designed to be used with its companion Spry app (via BLE) so that anonymous usage statistics may be monitored. The expected shelf life of the device is longer than 2 years and the expected use life is at least 12-18 months.

Trial Locations (2)

94121-1563

Northern California Institute for Research and Education (NCIRE), San Francisco

68198-7835

University of Nebraska Medical Center, Omaha

Sponsors
All Listed Sponsors
collaborator

University of Nebraska

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

National Institute on Aging (NIA)

NIH

lead

Bone Health Technologies, Inc.

INDUSTRY