The RestEaze Ambulatory Sleep Monitor for Detection of Le... | NCT04508595

Studies
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance

NCT04508595

Sponsor

Tanzen Medical Inc

Status

Unknown status

Last Update Posted

Aug 11, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Sleep

Interventions

RestEaze

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2020Actual

Primary Completion Date

Jul 31, 2021Estimated

Completion Date

Aug 6, 2021Estimated

First Submitted Date

Aug 7, 2020

First Submission Date that Met QC Criteria

Aug 7, 2020

First Posted Date

Aug 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2020

Last Update Posted Date

Aug 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RestEaze	Diagnostic Test	Wearable band to detect leg movements of sleep

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Algorithm	Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages between 5 -75
General good health and ambulatory
Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG
Reports no significant problems sleeping in a new bed and bedroom away from home
(If applicable) Parent or guardian available to spend the night with the child during the sleep study

Exclusion Criteria:

• Amputation that would preclude use of wrist actigraph or the RestEaze device

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Outpatients presenting to sleep medicine clinic for evaluation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Justin Brooks, MD,PhD	Contact	7575811363		jrybrooks@tanzenmed.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Comprehensive Sleep Center	Recruiting	Milpitas	California	95035	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided