CompletedNot Applicable

ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME

United States21 participantsStarted 2020-11-23

Plain-language 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

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Diagnosis of typical Rett Syndrome according to the revised Clinical Diagnostic Criteria1 and presence of a disease causing MECP2 genetic mutation.
. 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.
. Live within approximately 50 to 60 miles of MIT.
. Primary language English.
. Approximately 4 people or less living in the home. This does not include visiting caregivers.
. Must have home access to Wi-Fi.

Exclusion criteria

. Inability of patient to sleep alone in their own room.
. Pets in the home, or caregivers unwilling to keep pets out of the bedroom monitored by Emerald during the Observation Period.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Emerald respiratory function in Rett patients

Timeframe: 4 weeks

Trial details

NCT IDNCT04514549

SponsorRett Syndrome Research Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-01

View on ClinicalTrials.gov More Rett Syndrome trials