NCT04514549

ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME

Assessing Emerald and MC10 nPoint Biosensors for Rett Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Rett Syndrome Research Trust · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a pilot study of the Emerald device in Rett syndrome patients diagnosed with a confirmed MECP2 mutation. MC10 BioStamp nPoint patches will also be assessed with the goal to develop Rett-specific breathing algorithms

Detailed description

The study consists of two sequential cohorts with a total of approximately 20 patients enrolled. Patients in each cohort may participate for up to 4 weeks. Each participant will have up to 2 Emerald devices installed in their home for monitoring sleep, breathing and movement, and will use between 3 and 9 nPoint patches for determining proper patch placement for detecting breathing signals. The study will consist of a Screening visit, an Observation period, and a Follow-up phone call. The Screening Period will be one day in clinic, the Observation period will be up to 4 weeks at home and the Follow up phone call will be performed at the completion of the Observation Period.

Conditions

• Rett Syndrome

Interventions

Type	Name	Description
DEVICE	Emerald	The Emerald is a wireless sensor that can track the motion, breathing, and sleep of subjects without touching or requiring any interaction with the subjects, allowing them to go about their normal lives. The physical device is roughly a 30 x 35 x 5 cm box that contains directional antennas and a motherboard to process these signals. In typical operation, the device is mounted onto a wall within a clinic or home setting using peel-away (reversible) mount strips.

Timeline

• Start date: 2020-11-23
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2020-08-17
• Last updated: 2024-11-14

Locations

1 site across 1 country: United States