Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514549
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2020-08-12
Brief Title:
ASSESSING EMERALD AND MC10 BIOSTAMP nPOINT BIOSENSORS FOR RETT SYNDROME
Sponsor:
Rett Syndrome Research Trust
Organization:
Rett Syndrome Research Trust
Study Overview
Official Title:
Assessing Emerald and MC10 nPoint Biosensors for Rett Syndrome
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None