Sleep Study Among Inpatients With TBI in an Acute Rehabil... | NCT02236676

Studies
Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital

NCT02236676

Sponsor

Kessler Foundation

Status

Completed

Last Update Posted

Sep 5, 2021Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Motor Learning in TBI

Interventions

Nap after rehearsal trials

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2014Actual

Primary Completion Date

May 31, 2019Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Sep 8, 2014

First Submission Date that Met QC Criteria

Sep 8, 2014

First Posted Date

Sep 10, 2014Estimated

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 30, 2021

Last Update Posted Date

Sep 5, 2021Actual

Name	Class
New Jersey Commission on Brain Injury Research	OTHER

Description Module

Brief Summary

The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nap after rehearsal trials	Active Comparator	A 30-minute daytime nap after training	Behavioral: Nap after rehearsal trials
Resting while awake	Placebo Comparator	Placebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed.	Behavioral: Nap after rehearsal trials

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nap after rehearsal trials	Behavioral	Behavioral	Nap after rehearsal trials Resting while awake

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement on Motor Functioning Test	Change scores from day 1 to day 3 will be compared in both Nap and No Nap conditions	Three Nights and Three Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have a Traumatic Brain Injury.
Must have been a Kessler Institute for Rehabilitation inpatient for at least three days.

Exclusion Criteria:

Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the WatchPAT-200/actigragh.
Movement disorder or spasticity affecting both upper extremities
Patients who are ventilator-dependent.
Patients who are on contact precautions for C.diff or other highly contagious diseases.
Patients with neurological disorders other than TBI.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kessler Foundation		West Orange	New Jersey	07052	United States