Prevention of Delirium After Bone Marrow Transplantation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Delirium |
Device: Bright light therapy Device: Sham light |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) |
- Incidence of delirium (Time to the development of 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 ] [ Designated as safety issue: No ]Monday, Wednesday, and Friday assessments will begin the day after transplant and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
- Length and severity of delirium episodes [ Time Frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant ] [ Designated as safety issue: No ]Monday, Wednesday, and Friday assessments include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments beginning the day after transplant until day 28 post-transplant or discharge, whichever comes first
- 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 ] [ Designated as safety issue: No ]
- Hospital length of stay [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ] [ Designated as safety issue: No ]
- Complications (falls, aspiration, infections, nutritional deficits) [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ] [ Designated as safety issue: No ]Available and pertinent laboratory data will be collected including serum electrolytes, serum BUN, serum creatinine, TSH, LFTs, CBC with differential, Alkaline phosphatase and urinalysis. These tests are performed as part of routine clinical care on patients undergoing HSCT.
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: DL930 Day-Light Classic by Uplift Tecnologies MODIFIED to create placebo boxes.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 skin cancer
- 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
- On-going Major Depressive Episode
- History of suicide events
- Mini-Mental State Examination(MMSE) < 23 From initial psychiatric/cognitive assessment
- Delirium Rating Scale-Revised 98 (DRS-98) > 12 From initial psychiatric/cognitive assessment
Contacts and Locations| Contact: Carlos Fernandez-Robles, MD | 617-643-2410 | CFERNANDEZ-ROBLES@PARTNERS.ORG |
| Contact: Kailyn Kuzmuk, BA | 617-726-8344 | KKUZMUK@PARTNERS.ORG |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Carlos Fernandez-Robles, MD 617-643-2410 CFERNANDEZ-ROBLES@PARTNERS.ORG | |
| Contact: William Pirl, MD 617-724-4800 WPIRL@PARTNERS.ORG | |
| Principal Investigator: Carlos Fernandez-Robles, MD | |
| Sub-Investigator: William Pirl, MD | |
| Principal Investigator: | Carlos Fernandez-Robles, MD | Massachusetts General Hospital |
More Information
Publications:
| Responsible Party: | Carlos Fernandez-Robles, Principal Investigator, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01700816 History of Changes |
| Other Study ID Numbers: | 2010P002801 |
| Study First Received: | October 1, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Delirium Hematopoietic stem cell transplantation Bone marrow transplantation Bright Light Therapy |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013