Prevention of Delirium After Bone Marrow Transplantation

Not Applicable

Terminated

Conditions: Delirium

Interventions: Device: Bright light therapy
Device: Sham light

Registration Number: NCT01700816

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 40

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright light therapy	Bright light therapy	2500 Lux gaze directed every morning from 8 am until 8:30 am
Sham light	Sham light	\<1000 Lux gaze directed every morning from 8 am until 8:30 am

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale	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)

Secondary Outcome Measures

Name	Time	Method
Average Dose of Antipsychotic Medications Required to Manage Delirium	From admission to hospital to discharge, an expected average of 28 days post-transplant
Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)	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
Serum Creatinine and Blood Urea Nitrogen (BUN)	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.
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)	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).
White Blood Cells (WBC)	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.
Hemoglobin (HGB)	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.
Hospital Length of Stay	From admission to hospital to discharge, an expected average of 28 days post-transplant
Red Blood Cells (RBC)	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.
Hematocrit (HCT)	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.
Platelet Count	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.