Prevention of Delirium After Bone Marrow Transplantation

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01700816
• Other study ID #: 2010P002801
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2012
• Last updated: May 16, 2013
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: Carlos Fernandez-Robles, MD
• Phone: 617-643-2410
• Email: CFERNANDEZ-ROBLES[@]PARTNERS.ORG
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (27)

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. — View Citation

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. — View Citation

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.

Fann JR, Roth-Roemer S, Burington BE, Katon WJ, Syrjala KL. Delirium in patients undergoing hematopoietic stem cell transplantation. Cancer. 2002 Nov 1;95(9):1971-81. — View Citation

Fortuyn HD, Schoemaker J. Treatment of delirium with phototherapy: a case report. Eur Psychiatry. 1997;12(7):367-8. — View Citation

Fricchione GL, Nejad SH, Esses JA, Cummings TJ Jr, Querques J, Cassem NH, Murray GB. Postoperative delirium. Am J Psychiatry. 2008 Jul;165(7):803-12. doi: 10.1176/appi.ajp.2008.08020181. — View Citation

Hshieh TT, Fong TG, Marcantonio ER, Inouye SK. Cholinergic deficiency hypothesis in delirium: a synthesis of current evidence. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):764-72. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. — View Citation

Kirshner HS. Delirium: a focused review. Curr Neurol Neurosci Rep. 2007 Nov;7(6):479-82. Review. — View Citation

Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. Epub 2006 Aug 16. — View Citation

Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Markey SP. Light suppresses melatonin secretion in humans. Science. 1980 Dec 12;210(4475):1267-9. — View Citation

Lipowski ZJ. Delirium (acute confusional states). JAMA. 1987 Oct 2;258(13):1789-92. — View Citation

Liptzin B, Laki A, Garb JL, Fingeroth R, Krushell R. Donepezil in the prevention and treatment of post-surgical delirium. Am J Geriatr Psychiatry. 2005 Dec;13(12):1100-6. — View Citation

McIntyre IM, Norman TR, Burrows GD, Armstrong SM. Human melatonin suppression by light is intensity dependent. J Pineal Res. 1989;6(2):149-56. — View Citation

Minden SL, Carbone LA, Barsky A, Borus JF, Fife A, Fricchione GL, Orav EJ. Predictors and outcomes of delirium. Gen Hosp Psychiatry. 2005 May-Jun;27(3):209-14. — View Citation

Nasreddine ZS, Phillips NA, Bédirian 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. — View Citation

Petterborg LJ, Kjellman BF, Thalén 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. — View Citation

Prakanrattana U, Prapaitrakool S. Efficacy of risperidone for prevention of postoperative delirium in cardiac surgery. Anaesth Intensive Care. 2007 Oct;35(5):714-9. — View Citation

Reitan RM. Validity of the Trail Making test as an indicator of organic brain damage. Perceptual and Motor Skills 8: 271-276, 1958.

Sampson EL, Raven PR, Ndhlovu PN, Vallance A, Garlick N, Watts J, Blanchard MR, Bruce A, Blizard R, Ritchie CW. A randomized, double-blind, placebo-controlled trial of donepezil hydrochloride (Aricept) for reducing the incidence of postoperative delirium after elective total hip replacement. Int J Geriatr Psychiatry. 2007 Apr;22(4):343-9. — View Citation

Schmitz M, Frey R, Pichler P, Röpke 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. — View Citation

Shigeta H, Yasui A, Nimura Y, Machida N, Kageyama M, Miura M, Menjo M, Ikeda K. Postoperative delirium and melatonin levels in elderly patients. Am J Surg. 2001 Nov;182(5):449-54. — View Citation

Tabet N, Howard R. Non-pharmacological interventions in the prevention of delirium. Age Ageing. 2009 Jul;38(4):374-9. doi: 10.1093/ageing/afp039. Epub 2009 May 21. Review. — View Citation

Taguchi T, Yano M, Kido Y. Influence of bright light therapy on postoperative patients: a pilot study. Intensive Crit Care Nurs. 2007 Oct;23(5):289-97. Epub 2007 Aug 9. — View Citation

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. Erratum in: J Neuropsychiatry Clin Neurosci 2001 Summer;13(3):433. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium (Time to the development of 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	No
Secondary	Length and severity of delirium episodes	Monday, Wednesday, and Friday assessments include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.	From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant	No
Secondary	Average dose of antipsychotic medications required to manage delirium		From admission to hospital to discharge, an expected average of 28 days post-transplant	No
Secondary	Hospital length of stay		From admission to hospital to discharge, an expected average of 28 days post-transplant	No
Secondary	Complications (falls, aspiration, infections, nutritional deficits)	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.	From admission to hospital to discharge, an expected average of 28 days post-transplant	No