Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital

August 30, 2021 updated by: Anthony Lequerica, Kessler Foundation

Sleep, Procedural Learning & Therapeutic Engagement Among Inpatients With

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nap after rehearsal trials
A 30-minute daytime nap after training
Behavioral: Nap after rehearsal trials
Behavioral
Placebo Comparator: Resting while awake
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
Behavioral

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

New Jersey Commission on Brain Injury Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2014

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-833-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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