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Biometric Device

Cohort 1 for Rett Syndrome

N/A
Waitlist Available
Led By David Lieberman, MD
Research Sponsored by Rett Syndrome Research Trust
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

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

Eligible Conditions
  • Rett Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Emerald respiratory function in Rett patients
Secondary study objectives
MC10

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment0 Interventions
will enroll approximately 15 patients. Patients with pronounced respiratory dysfunction, tremors, seizures, and/or other expanded features of Rett syndrome deemed appropriate may be enrolled. If Emerald is continued, all patients are observed via Emerald to capture sleep staging, movement and breathing up to for approximately 4 weeks. Caregivers will keep a daily questionnaire diary of the patient's anxiety, sleep and seizures. Ongoing assessment of MC10 nPoint data may lead to the use of more or less sensors, changes in duration of sensor data collection, or placement as Cohort 2 progresses.
Group II: Cohort 1Experimental Treatment1 Intervention
will enroll approximately 5 patients with pronounced respiratory dysfunction. Patients may be enrolled with tremors and or seizures. All patients will be observed via Emerald to capture sleep staging, movement and breathing for up to approximately 4 weeks. Caregivers will keep a daily questionnaire diary of the patient's anxiety, sleep and seizures. MC10 nPoint data will be captured for at least two 24-hour periods in each of the 4 weeks to assess patch placements for breathing detection. Ongoing assessment of MC10 nPoint data may lead to the use of more or less sensors, changes in duration of sensor data collection, or placement as Cohort 1 progresses.Preliminary results from Cohort 1 will determine if Emerald will continue to be evaluated and will inform on MC10 nPoint optimizations for Cohort 2. If preliminary results indicate Emerald is not an effective device, then Emerald will be discontinued
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emerald
2020
N/A
~30

Find a Location

Who is running the clinical trial?

Rett Syndrome Research TrustLead Sponsor
7 Previous Clinical Trials
5,367 Total Patients Enrolled
7 Trials studying Rett Syndrome
5,367 Patients Enrolled for Rett Syndrome
David Lieberman, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
3,200 Total Patients Enrolled
~4 spots leftby Sep 2025
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