Prevention of Delirium After Bone Marrow Transplantation

May 26, 2017 updated by: Carlos Fernandez-Robles, Massachusetts General Hospital

Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)

The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition.

Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there).

Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.

Study Type

Interventional

Enrollment (Actual)

40

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 or older
  • Male or female
  • Patients scheduled to undergo HSCT
  • English speaking

Exclusion Criteria:

  • Previous history of bipolar affective disorder
  • On-going delirium
  • History of substance abuse/dependence within 6 months prior to HSCT
  • History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins
  • History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria
  • Eye condition that makes eyes vulnerable to light damage
  • Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort
  • Established primary insomnia

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bright light therapy
2500 Lux gaze directed every morning from 8 am until 8:30 am
Device: Bright light therapy
The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
Other Names:
  • DL930 Day-Light Classic by Uplift Technologies Inc.
PLACEBO_COMPARATOR: Sham light
<1000 Lux gaze directed every morning from 8 am until 8:30 am
Device: Sham light
The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
Other Names:
  • DL930 Day-Light Classic Uplift Tecnologies placebo box

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
Time Frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
Time Frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant

Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.

10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.

A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium
From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant
Average Dose of Antipsychotic Medications Required to Manage Delirium
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
From admission to hospital to discharge, an expected average of 28 days post-transplant
Hospital Length of Stay
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
From admission to hospital to discharge, an expected average of 28 days post-transplant
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
From admission to hospital to discharge, an expected average of 28 days post-transplant
Serum Creatinine and Blood Urea Nitrogen (BUN)
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
From admission to hospital to discharge, an expected average of 28 days post-transplant
Red Blood Cells (RBC)
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
From admission to hospital to discharge, an expected average of 28 days post-transplant
White Blood Cells (WBC)
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
From admission to hospital to discharge, an expected average of 28 days post-transplant
Hemoglobin (HGB)
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
From admission to hospital to discharge, an expected average of 28 days post-transplant
Hematocrit (HCT)
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
From admission to hospital to discharge, an expected average of 28 days post-transplant
Platelet Count
Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
From admission to hospital to discharge, an expected average of 28 days post-transplant

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Carlos Fernandez-Robles, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (ESTIMATE)

October 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P002801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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