Rett SyndromeNCT04514549
ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME
An observational study of Rett Syndrome, run by Rett Syndrome Research Trust at 1 site in United States.
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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rett Syndrome
- What is being tested?
- Emerald
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients with Diagnosis of typical Rett Syndrome according to the revised Clinical Diagnostic Criteria and presence of a disease-causing MECP2 genetic mutation.
Who may be able to join
- 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.
Who cannot join
- 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.
- Plans to take a prolonged vacation or to otherwise be out of the home during the Observation Period.
- Participation in another device study that could interfere with this study.
- Active implantable devices such as pacemakers or defibrillators.
- Known allergies or hypersensitivities to adhesives.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Assessing Emerald and MC10 nPoint Biosensors for Rett Syndrome
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
Read the 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
- Being tested
- Emerald
- Medical subject headings
- Rett Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmeraldDevice
Also called MC 10
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 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 Receives: Device: Emerald | |
| Cohort 2 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emerald respiratory function in Rett patients
Suitability of Emerald technology to assess sleep staging and
Measured: 4 weeks
Secondary outcomes (1)
MC10
Determination of MC10 BioStamp nPoint patch placement for detecting breathing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start23 Nov 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rett Syndrome Research Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Lieberman, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514549
- Sponsor's protocol ID
- SENS-101-RSRT
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Emerald and MC10 nPoint Biosensors for Rett Syndrome
- ClinicalTrials.gov ID
- NCT04514549
- Acronym / sponsor ID
- SENS-101-RSRT
- Conditions
- Rett Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rett Syndrome Research TrustUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Emeraldwill 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 |
| Cohort 2 | – | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients with Diagnosis of typical Rett Syndrome according to the revised Clinical Diagnostic Criteria and presence of a disease-causing MECP2 genetic mutation.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Plans to take a prolonged vacation or to otherwise be out of the home during the Observation Period.
- Participation in another device study that could interfere with this study.
- Active implantable devices such as pacemakers or defibrillators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmeraldAlso: MC 10The 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. | Device | Cohort 1 |
Primary outcome
Emerald respiratory function in Rett patients
Time frame: 4 weeks
Suitability of Emerald technology to assess sleep staging and
1 secondary outcome
MC10
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Lieberman, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rett Syndrome, run by Rett Syndrome Research Trust at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emerald respiratory function in Rett patients (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.