ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME

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Brief Title

ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME

Official Title

Assessing Emerald and MC10 nPoint Biosensors for Rett Syndrome

Brief 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.
    


Study Type

Observational


Primary Outcome

Emerald respiratory function in Rett patients

Secondary Outcome

 MC10

Condition

Rett Syndrome

Intervention

Emerald

Study Arms / Comparison Groups

 Cohort 1
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

November 23, 2020

Completion Date

August 2022

Primary Completion Date

August 2022

Eligibility Criteria

        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.
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

David Lieberman, MD, 617-355-5111, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04514549

Organization ID

SENS-101-RSRT


Responsible Party

Sponsor

Study Sponsor

Rett Syndrome Research Trust


Study Sponsor

David Lieberman, MD, Principal Investigator, Boston Children's Hospital


Verification Date

April 2022