Delirium
Conditions
Keywords
Delirium, Hematopoietic stem cell transplantation, Bone marrow transplantation, Bright Light Therapy
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.
Interventions
DEVICEBright 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.
DEVICESham 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.
Sponsors
American Cancer Society, Inc.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bright Light Therapy 2500 Lux gaze directed every morning from 8 am until 8:30 am
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. | 21 |
| Sham Light \<1000 Lux gaze directed every morning from 8 am until 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. | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Sham Light | Total | Bright Light Therapy |
|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 14.15 | 53.2 years STANDARD_DEVIATION 13.49 | 53.3 years STANDARD_DEVIATION 12.84 |
| Highest Education Level 11th grade or less | 0 Participants | 1 Participants | 1 Participants |
| Highest Education Level Completed College | 7 Participants | 19 Participants | 12 Participants |
| Highest Education Level High School degree/GED | 6 Participants | 8 Participants | 2 Participants |
| Highest Education Level Some College | 2 Participants | 4 Participants | 2 Participants |
| Marital Status Married/Partnered | 13 Participants | 25 Participants | 12 Participants |
| Marital Status Single/Divorced/Widowed | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Non Hispanic White | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 28 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
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)
Time frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
Population: Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bright Light Therapy | Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale | 1 Participants |
| Sham Light | Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale | 0 Participants |
Secondary
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
Population: Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.
Secondary
Hematocrit (HCT)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bright Light Therapy | Hematocrit (HCT) | 28.20 volume percentage (vol%) of red blood ce |
| Sham Light | Hematocrit (HCT) | 26.70 volume percentage (vol%) of red blood ce |
Secondary
Hemoglobin (HGB)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bright Light Therapy | Hemoglobin (HGB) | 9.70 g/dl |
| Sham Light | Hemoglobin (HGB) | 9.55 g/dl |
Secondary
Hospital Length of Stay
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bright Light Therapy | Hospital Length of Stay | 18 days |
| Sham Light | Hospital Length of Stay | 18.5 days |
Secondary
Platelet Count
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bright Light Therapy | Platelet Count | 39 thousand cells/uL |
| Sham Light | Platelet Count | 33.5 thousand cells/uL |
Secondary
Red Blood Cells (RBC)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bright Light Therapy | Red Blood Cells (RBC) | 3.21 M/uL |
| Sham Light | Red Blood Cells (RBC) | 2.93 M/uL |
Secondary
Serum Creatinine and Blood Urea Nitrogen (BUN)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bright Light Therapy | Serum Creatinine and Blood Urea Nitrogen (BUN) | Blood Urea Nitrogen (BUN) | 9 mg/dl |
| Bright Light Therapy | Serum Creatinine and Blood Urea Nitrogen (BUN) | Serum Creatinine | 0.66 mg/dl |
| Sham Light | Serum Creatinine and Blood Urea Nitrogen (BUN) | Blood Urea Nitrogen (BUN) | 8.5 mg/dl |
| Sham Light | Serum Creatinine and Blood Urea Nitrogen (BUN) | Serum Creatinine | 0.75 mg/dl |
Secondary
Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
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
Time frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant
Population: Only one case of delirium developed, and only an MDAS score was collected for this participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bright Light Therapy | Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS) | 18 units on a scale |
Secondary
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
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).
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bright Light Therapy | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Sodium (Na) | 139 mmol/L |
| Bright Light Therapy | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Potassium (K) | 3.6 mmol/L |
| Bright Light Therapy | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Chloride (Cl) | 105 mmol/L |
| Bright Light Therapy | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Carbon Dioxide (CO2) | 24.9 mmol/L |
| Sham Light | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Carbon Dioxide (CO2) | 25.10 mmol/L |
| Sham Light | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Sodium (Na) | 138.0 mmol/L |
| Sham Light | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Chloride (Cl) | 103.0 mmol/L |
| Sham Light | Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) | Potassium (K) | 3.80 mmol/L |
Secondary
White Blood Cells (WBC)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Population: 8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bright Light Therapy | White Blood Cells (WBC) | 2.30 K/uL |
| Sham Light | White Blood Cells (WBC) | 4.75 K/uL |