ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME

Rett Syndrome Clinical Trial

Official title:

Assessing Emerald and MC10 nPoint Biosensors for Rett Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514549
• Other study ID #: SENS-101-RSRT
• Status: Completed
• Start date: November 23, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Rett Syndrome Research Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Prior to the conduct of any study-specific procedures, the parent/caregiver/LAR must provide written informed consent. If the caregiver attending the clinic visits is not the parent or LAR, written consent must be obtained from the parent or LAR for the caregiver's participation in the study.

2. Diagnosis of typical Rett Syndrome according to the revised Clinical Diagnostic Criteria1 and presence of a disease causing MECP2 genetic mutation.

3. The patient's parent/caregiver/LAR must be able to understand the nature of the study and to allow for the completion of study assessments. The same parent/caregiver/LAR must be capable of providing reliable information about the patient's condition.

4. Live within approximately 50 to 60 miles of MIT.

5. Primary language English.

6. Approximately 4 people or less living in the home. This does not include visiting caregivers.

7. Must have home access to Wi-Fi.

Exclusion Criteria:

1. Inability of patient to sleep alone in their own room.

2. Pets in the home, or caregivers unwilling to keep pets out of the bedroom monitored by Emerald during the Observation Period.

3. Plans to take a prolonged vacation or to otherwise be out of the home during the Observation Period.

4. Participation in another device study that could interfere with this study.

5. Active implantable devices such as pacemakers or defibrillators.

6. Known allergies or hypersensitivities to adhesives.

7. Patients with any condition that, in the opinion of the principal investigator, might interfere with the conduct of the study, confound interpretation of the study results, endanger their own well-being, or who may otherwise not be suitable for the study.

Related Conditions & MeSH terms

• Rett Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rett Syndrome Research Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emerald respiratory function in Rett patients	Suitability of Emerald technology to assess sleep staging and	4 weeks
Secondary	MC10	Determination of MC10 BioStamp nPoint patch placement for detecting breathing	8 weeks