Prevention of Delirium After Bone Marrow Transplantation

Mass General Brigham

Status: Terminated

Conditions: Delirium

Treatments: Device: Bright light therapy; Device: Sham light

Study type: Interventional

Funder types: Other

Identifiers

NCT01700816

2010P002801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Bright light therapy

Experimental group

Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Treatment:

Device: Bright light therapy

Sham light

Placebo Comparator group

Description:

\<1000 Lux gaze directed every morning from 8 am until 8:30 am

Treatment:

Device: Sham light