Prevention of Delirium After Bone Marrow Transplantation

NCT01700816 | Terminated Results DMC

• 1 other identifier: 2010P002801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Delirium; Hematopoietic stem cell transplantation; Bone marrow transplantation; Bright Light Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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)

  From admission to hospital to discharge, an expected average of 28 days post-transplant

• Serum Creatinine and Blood Urea Nitrogen (BUN)

  From admission to hospital to discharge, an expected average of 28 days post-transplant

Study Arms (2)

Bright light therapy

EXPERIMENTAL

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

Device: Bright light therapy

Sham light

PLACEBO COMPARATOR

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

Device: Sham light

Interventions

Bright light therapy DEVICE

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.

Also known as: DL930 Day-Light Classic by Uplift Technologies Inc.

Bright light therapy

Sham light DEVICE

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.

Also known as: DL930 Day-Light Classic Uplift Tecnologies placebo box

Sham light

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (27)

• Kirshner HS. Delirium: a focused review. Curr Neurol Neurosci Rep. 2007 Nov;7(6):479-82. doi: 10.1007/s11910-007-0074-7.

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• Inouye SK, Schlesinger MJ, Lydon TJ. Delirium: a symptom of how hospital care is failing older persons and a window to improve quality of hospital care. Am J Med. 1999 May;106(5):565-73. doi: 10.1016/s0002-9343(99)00070-4.

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• Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.

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• Petterborg LJ, Kjellman BF, Thalen BE, Wetterberg L. Effect of a 15 minute light pulse on nocturnal serum melatonin levels in human volunteers. J Pineal Res. 1991 Jan;10(1):9-13. doi: 10.1111/j.1600-079x.1991.tb00003.x.

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• Schmitz M, Frey R, Pichler P, Ropke H, Anderer P, Saletu B, Rudas S. Sleep quality during alcohol withdrawal with bright light therapy. Prog Neuropsychopharmacol Biol Psychiatry. 1997 Aug;21(6):965-77. doi: 10.1016/s0278-5846(97)00092-4.

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• Beglinger LJ, Duff K, Van Der Heiden S, Parrott K, Langbehn D, Gingrich R. Incidence of delirium and associated mortality in hematopoietic stem cell transplantation patients. Biol Blood Marrow Transplant. 2006 Sep;12(9):928-35. doi: 10.1016/j.bbmt.2006.05.009.

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  PMID: 12404292 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

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  BACKGROUND

• Derogatis LR, Savitz, KL. The SCL-90-R and the Brief Symptom Inventory (BSI) in Primary Care In: M.E.Maruish, ed. Handbook of psychological assessment in primary care settings 236: 297,334, 2000. Mahwah, NJ: Lawrence Erlbaum Associates.

  BACKGROUND

• Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229.

  PMID: 11449030 BACKGROUND

• Breitbart W, Rosenfeld B, Roth A, Smith MJ, Cohen K, Passik S. The Memorial Delirium Assessment Scale. J Pain Symptom Manage. 1997 Mar;13(3):128-37. doi: 10.1016/s0885-3924(96)00316-8.

  PMID: 9114631 BACKGROUND

• Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Markey SP. Light suppresses melatonin secretion in humans. Science. 1980 Dec 12;210(4475):1267-9. doi: 10.1126/science.7434030.

  PMID: 7434030 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Results Point of Contact

• Title: Carlos Fernandez Robles MD
• Organization: Massachusetts General Hospital

cfernandez-robles@mgh.harvard.edu

6176432410

Study Officials

• Carlos Fernandez-Robles, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)