Prevention of Delirium After Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Device: Bright light therapy
* Device: Sham light


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright light therapy<br>2500 Lux gaze directed every morning from 8 am until 8:30 am | Device: Bright light therapy<br>* 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.<br>* Other names: DL930 Day-Light Classic by Uplift Technologies Inc.;|
| Placebo Comparator: Sham light<br><1000 Lux gaze directed every morning from 8 am until 8:30 am | Device: Sham light<br>* 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.<br>* 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 | 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) | 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 |  | From admission to hospital to discharge, an expected average of 28 days post-transplant | 
| Hospital Length of Stay |  | From admission to hospital to discharge, an expected average of 28 days post-transplant | 
| Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium, Hematopoietic stem cell transplantation, Bone marrow transplantation, Bright Light Therapy