Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital

NCT ID: NCT02236676

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-28

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Motor Learning in TBI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nap after rehearsal trials

A 30-minute daytime nap after training

Group Type ACTIVE_COMPARATOR

Nap after rehearsal trials

Intervention Type BEHAVIORAL

Behavioral

Resting while awake

Placebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed.

Group Type PLACEBO_COMPARATOR

Nap after rehearsal trials

Intervention Type BEHAVIORAL

Behavioral

Interventions

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Nap after rehearsal trials

Behavioral

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Jersey Commission on Brain Injury Research

OTHER

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Anthony Lequerica

Senior Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R-833-14

Identifier Type: -

Identifier Source: org_study_id

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