Trial Outcomes & Findings for Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue (NCT NCT03198754)
NCT ID: NCT03198754
Last Updated: 2020-08-11
Results Overview
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
Baseline, Day 2, 7, 14, 28 and 90
Results posted on
2020-08-11
Participant Flow
89 consented, but 16 not enrolled
Participant milestones
| Measure |
Circadian Active Bright White Light (BWL)
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
35
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Circadian Active Bright White Light (BWL)
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Ineligible
|
2
|
1
|
Baseline Characteristics
Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue
Baseline characteristics by cohort
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.18 years
STANDARD_DEVIATION 8.507 • n=39 Participants
|
58.58 years
STANDARD_DEVIATION 7.521 • n=41 Participants
|
60.04 years
STANDARD_DEVIATION 8.083 • n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2, 7, 14, 28 and 90Population: Data available only for participants who completed instrument for respective study visits.
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
FACIT-Fatigue Scale
Baseline
|
37.00 score on a scale
Standard Deviation 9.80
|
35.06 score on a scale
Standard Deviation 10.51
|
|
FACIT-Fatigue Scale
Day 2
|
38.71 score on a scale
Standard Deviation 7.62
|
35.00 score on a scale
Standard Deviation 11.32
|
|
FACIT-Fatigue Scale
Day 7
|
29.16 score on a scale
Standard Deviation 11.32
|
26.37 score on a scale
Standard Deviation 13.49
|
|
FACIT-Fatigue Scale
Day 14
|
35.97 score on a scale
Standard Deviation 8.41
|
29.94 score on a scale
Standard Deviation 13.59
|
|
FACIT-Fatigue Scale
Day 28
|
38.17 score on a scale
Standard Deviation 11.26
|
35.46 score on a scale
Standard Deviation 10.07
|
|
FACIT-Fatigue Scale
Day 90
|
42.30 score on a scale
Standard Deviation 8.24
|
38.86 score on a scale
Standard Deviation 9.49
|
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: Instrument not used and data not collected.
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Tested for its psychometric properties in cancer patients receiving radiotherapy, patients with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians, it was found to have good Test-retest Reliability (r=0.80) and great Internal Consistency (Cronbach's alpha = 0.92).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 30 and Day 90Population: Data available only for participants who completed instrument for respective study visits.
The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
The Pittsburgh Sleep Quality Index
Day 90 after discharge
|
4.80 score on a scale
Standard Deviation 3.41
|
6.30 score on a scale
Standard Deviation 3.74
|
|
The Pittsburgh Sleep Quality Index
Baseline
|
6.03 score on a scale
Standard Deviation 3.11
|
7.59 score on a scale
Standard Deviation 4.58
|
|
The Pittsburgh Sleep Quality Index
Day 30 after discharge
|
5.79 score on a scale
Standard Deviation 3.60
|
6.13 score on a scale
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Baseline and 30 days post hospital dischargePopulation: Data available only for participants who completed instrument for respective study visits.
Quality of life assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=15 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=13 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
SF-36 Scale
Physicial Limitations Scale Day30 after discharge
|
77.0833 score on a scale
Standard Deviation 25.20747
|
77.5000 score on a scale
Standard Deviation 25.61738
|
|
SF-36 Scale
Energy Fatigue Scale Baseline
|
63.3333 score on a scale
Standard Deviation 11.77985
|
62.5000 score on a scale
Standard Deviation 15.72882
|
|
SF-36 Scale
Pain Scale Day 30 after discharge
|
79.1667 score on a scale
Standard Deviation 20.41241
|
72.5000 score on a scale
Standard Deviation 28.50439
|
|
SF-36 Scale
Emotional Well Being Scale Baseline
|
76.000 score on a scale
Standard Deviation 17.13393
|
75.3846 score on a scale
Standard Deviation 19.83910
|
|
SF-36 Scale
Emotional Well Being Scale Day 30 after discharge
|
89.1667 score on a scale
Standard Deviation 8.61201
|
76.0000 score on a scale
Standard Deviation 16.35543
|
|
SF-36 Scale
General Health Scale Baseline
|
65.2778 score on a scale
Standard Deviation 22.58508
|
52.8846 score on a scale
Standard Deviation 17.95253
|
|
SF-36 Scale
General Health Scale Day 30 after discharge
|
63.8889 score on a scale
Standard Deviation 22.77100
|
58.3333 score on a scale
Standard Deviation 27.63854
|
|
SF-36 Scale
Physical Functioning Scale Baseline
|
66.3333 score on a scale
Standard Deviation 29.48769
|
64.4872 score on a scale
Standard Deviation 30.49275
|
|
SF-36 Scale
Physical Functioning Scale Day 30 after discharge
|
78.3333 score on a scale
Standard Deviation 16.32993
|
75.0000 score on a scale
Standard Deviation 23.97916
|
|
SF-36 Scale
Limitations due to Physical Health Scale Baseline
|
64.1667 score on a scale
Standard Deviation 38.19787
|
55.6923 score on a scale
Standard Deviation 30.74105
|
|
SF-36 Scale
Energy Fatigue Scale Day 30 after discharge
|
69.7917 score on a scale
Standard Deviation 15.52048
|
61.2500 score on a scale
Standard Deviation 21.378
|
|
SF-36 Scale
Pain Scale Baseline
|
75.0000 score on a scale
Standard Deviation 24.54951
|
59.6154 score on a scale
Standard Deviation 29.82320
|
|
SF-36 Scale
Limitations due to Emotional Problems Baseline
|
86.1111 score on a scale
Standard Deviation 29.49083
|
75.0000 score on a scale
Standard Deviation 30.61862
|
|
SF-36 Scale
Emotional Limitations Scale Day 30 after discharge
|
83.3333 score on a scale
Standard Deviation 30.27650
|
78.3333 score on a scale
Standard Deviation 26.08746
|
|
SF-36 Scale
Social Functioning Scale Baseline
|
82.50000 score on a scale
Standard Deviation 22.05917
|
75.9615 score on a scale
Standard Deviation 19.40625
|
|
SF-36 Scale
Social Functioning Scale Day 30 after discharge
|
93.75000 score on a scale
Standard Deviation 15.30931
|
85.0000 score on a scale
Standard Deviation 16.29801
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 7, and Day 14 post transplantPopulation: Data available only for participants who completed instrument for respective study visits.
Number of participants with score 16 or greater on CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
Day 14, post transplant
|
12 Participants
|
17 Participants
|
|
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
baseline, prior to hospitalization
|
10 Participants
|
11 Participants
|
|
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
Day 2 post- transplant
|
9 Participants
|
8 Participants
|
|
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
Day 7, post-transplant
|
13 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 7, 14, 28, and 90Population: Data available only for participants who completed instrument for respective study visits.
CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
CES-D (Center for Epidemiologic Studies Depression Scale)
Day 7
|
15.13 score on a scale
Standard Deviation 9.01
|
17.93 score on a scale
Standard Deviation 11.16
|
|
CES-D (Center for Epidemiologic Studies Depression Scale)
baseline, prior to hospitalization
|
11.00 score on a scale
Standard Deviation 8.47
|
10.94 score on a scale
Standard Deviation 8.12
|
|
CES-D (Center for Epidemiologic Studies Depression Scale)
Day 2
|
12.48 score on a scale
Standard Deviation 9.64
|
12.48 score on a scale
Standard Deviation 9.26
|
|
CES-D (Center for Epidemiologic Studies Depression Scale)
Day 14
|
14.43 score on a scale
Standard Deviation 8.78
|
18.58 score on a scale
Standard Deviation 10.71
|
|
CES-D (Center for Epidemiologic Studies Depression Scale)
Day 28
|
9.75 score on a scale
Standard Deviation 9.03
|
10.27 score on a scale
Standard Deviation 7.94
|
|
CES-D (Center for Epidemiologic Studies Depression Scale)
Day 90
|
8.13 score on a scale
Standard Deviation 7.41
|
6.95 score on a scale
Standard Deviation 7.17
|
SECONDARY outcome
Timeframe: Baseline, Day 30, Day 90Population: Data available only for participants who completed instrument for respective study visits.
PANAS is a 20-item self-report measure of positive and negative affect. Each item rated on a 5-point scale of 1 (not at all) to 5 (extremely), each subscale from 1-5, full score from 1-5, with higher score indicating more symptoms. Change in PANAS at Day 30 and Day 90 as compared to baseline.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
The Positive and Negative Affect Schedule (PANAS)
PANAS Negative Baseline
|
1.6455 score on a scale
Standard Deviation .65154
|
1.9316 score on a scale
Standard Deviation .82060
|
|
The Positive and Negative Affect Schedule (PANAS)
PANAS Negative Day 30 after discharge
|
1.6524 score on a scale
Standard Deviation .90312
|
.93667 score on a scale
Standard Deviation 1.5950
|
|
The Positive and Negative Affect Schedule (PANAS)
PANAS Negative Day 90 after discharge
|
1.4333 score on a scale
Standard Deviation .70875
|
1.5417 score on a scale
Standard Deviation .90068
|
|
The Positive and Negative Affect Schedule (PANAS)
PANAS Positive Baseline
|
3.2475 score on a scale
Standard Deviation .98800
|
3.1351 score on a scale
Standard Deviation .92138
|
|
The Positive and Negative Affect Schedule (PANAS)
PANAS Positive Day 30 after discharge
|
3.3238 score on a scale
Standard Deviation .99242
|
2.6850 score on a scale
Standard Deviation .96588
|
|
The Positive and Negative Affect Schedule (PANAS)
PANAS Positive Day 90 after discharge
|
3.4778 score on a scale
Standard Deviation .94465
|
3.0208 score on a scale
Standard Deviation .89003
|
SECONDARY outcome
Timeframe: Baseline and Day 90Population: Thirty-eight participants were randomized to the bright white light condition (BWL) and 35 were randomized to the dim white light condition (DWL). Not all participants completed each measure at all time-points. For intent to treat analyses all participants need to be accounted for.
Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Change in Brief Symptoms Inventory-18 (BSI-18)
Baseline
|
.6560 T-score
Standard Deviation .49498
|
.4714 T-score
Standard Deviation .61354
|
|
Change in Brief Symptoms Inventory-18 (BSI-18)
Day 90
|
.3280 T-score
Standard Deviation .48206
|
.3763 T-score
Standard Deviation .67975
|
SECONDARY outcome
Timeframe: baseline, day 2, 7, and 14Population: Data available only for participants who completed instrument for respective study visits.
Simple numeric graphic rating scale, marked on a line numbering 0-100, with higher score indicating more fatigue. Replaces the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Fatigue Line Scale
Day 14
|
47.65 score on a scale
Standard Deviation 21.59
|
44.23 score on a scale
Standard Deviation 33.22
|
|
Fatigue Line Scale
Baseline
|
34.62 score on a scale
Standard Deviation 26.41
|
33.04 score on a scale
Standard Deviation 23.35
|
|
Fatigue Line Scale
Day 2
|
40.21 score on a scale
Standard Deviation 24.19
|
33.21 score on a scale
Standard Deviation 21.14
|
|
Fatigue Line Scale
Day 7
|
55.55 score on a scale
Standard Deviation 28.45
|
52.86 score on a scale
Standard Deviation 27.16
|
SECONDARY outcome
Timeframe: Baseline, Day 30 after Discharge, Day 90 after DischargePopulation: Thirty-eight participants were randomized to the bright white light condition (BWL) and 35 were randomized to the dim white light condition (DWL). Not all participants completed each measure at all time-points. For intent to treat analyses all participants need to be accounted for.
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a 30-item short form of the MFSI that measures five dimensions: general, physical, emotional, mental fatigue, and vigor. Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely). The total MFSI-SF score ranges from 0-4, with a higher score indicating a higher fatigue level.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=38 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=35 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
Baseline
|
3.1689 score on a scale
Standard Deviation 2.77373
|
3.0368 score on a scale
Standard Deviation 2.18310
|
|
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
Day 30 after Discharge
|
2.2365 score on a scale
Standard Deviation 2.02204
|
2.8088 score on a scale
Standard Deviation 2.30284
|
|
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
Day 90 after Discharge
|
2.2093 score on a scale
Standard Deviation 1.75925
|
2.2371 score on a scale
Standard Deviation 2.65162
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 7, 3rd day post Engraftment, DischargePopulation: Data available only for participants who completed instrument for respective study visits.
Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=27 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=27 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Sleep Latency
3rd day post Engraftment
|
7.1875 minutes
Standard Deviation 10.88252
|
4.0909 minutes
Standard Deviation 4.92718
|
|
Sleep Latency
Discharge, average 14 days
|
3.1250 minutes
Standard Deviation 5.40216
|
6.1579 minutes
Standard Deviation 7.55912
|
|
Sleep Latency
Baseline
|
6.1739 minutes
Standard Deviation 7.61370
|
12.1481 minutes
Standard Deviation 23.62154
|
|
Sleep Latency
Day 2
|
4.3000 minutes
Standard Deviation 8.90949
|
9.1538 minutes
Standard Deviation 14.94173
|
|
Sleep Latency
Day 7
|
6.8500 minutes
Standard Deviation 6.25153
|
4.7778 minutes
Standard Deviation 6.81251
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 7, 3rd day post Engraftment, DischargePopulation: Data available only for participants who completed instrument for respective study visits.
Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=27 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=27 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Sleep Efficiency
Day 7
|
86.2340 percentage of time
Standard Deviation 7.27702
|
86.3233 percentage of time
Standard Deviation 9.42600
|
|
Sleep Efficiency
Baseline
|
88.1517 percentage of time
Standard Deviation 12.11416
|
89.3481 percentage of time
Standard Deviation 6.34251
|
|
Sleep Efficiency
Day 2
|
87.3555 percentage of time
Standard Deviation 8.01844
|
86.4504 percentage of time
Standard Deviation 10.24487
|
|
Sleep Efficiency
3rd day post Engraftment
|
84.5994 percentage of time
Standard Deviation 7.92472
|
83.0605 percentage of time
Standard Deviation 13.49365
|
|
Sleep Efficiency
Discharge, average 14 days
|
85.1650 percentage of time
Standard Deviation 7.88246
|
84.5600 percentage of time
Standard Deviation 12.06957
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 7, 3rd day post Engraftment, DischargePopulation: Data available only for participants who completed instrument for respective study visits.
Wake time measured by actigraph. Wake time is the average number of minutes the participant spent awake each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=27 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=27 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Wake Time
Baseline
|
41.7391 minutes
Standard Deviation 50.64602
|
40.5556 minutes
Standard Deviation 37.40561
|
|
Wake Time
Day 2
|
56.1000 minutes
Standard Deviation 40.07743
|
57.2308 minutes
Standard Deviation 44.75382
|
|
Wake Time
Day 7
|
57.6000 minutes
Standard Deviation 42.40209
|
69.0370 minutes
Standard Deviation 57.24675
|
|
Wake Time
3rd day post Engraftment
|
68.1250 minutes
Standard Deviation 35.86805
|
84.6364 minutes
Standard Deviation 88.30981
|
|
Wake Time
Discharge, average 14 days
|
62.6875 minutes
Standard Deviation 33.40802
|
63.3158 minutes
Standard Deviation 57.05363
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 7, 3rd day post Engraftment, DischargePopulation: Data available only for participants who completed instrument for respective study visits.
Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=27 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=27 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Wake Percent
Discharge, average 14 days
|
12.6494 percentage of time
Standard Deviation 6.22923
|
13.0326 percentage of time
Standard Deviation 9.44681
|
|
Wake Percent
Baseline
|
9.4665 percentage of time
Standard Deviation 11.90539
|
7.9574 percentage of time
Standard Deviation 6.25857
|
|
Wake Percent
Day 2
|
11.5900 percentage of time
Standard Deviation 7.51981
|
11.0746 percentage of time
Standard Deviation 7.82651
|
|
Wake Percent
Day 7
|
11.9765 percentage of time
Standard Deviation 7.21864
|
12.3589 percentage of time
Standard Deviation 9.11993
|
|
Wake Percent
3rd day post Engraftment
|
13.1819 percentage of time
Standard Deviation 6.67063
|
15.7973 percentage of time
Standard Deviation 13.55268
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 7, 3rd day post Engraftment, DischargePopulation: Data available only for participants who completed instrument for respective study visits.
Sleep time measured by actigraph. Sleep time - average number of minutes the participant was asleep each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=27 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=27 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Sleep Time
Baseline
|
396.0000 minutes
Standard Deviation 106.94731
|
444.2407 minutes
Standard Deviation 120.45869
|
|
Sleep Time
Day 2
|
423.3500 minutes
Standard Deviation 102.93753
|
458.3077 minutes
Standard Deviation 122.00419
|
|
Sleep Time
Day 7
|
422.9500 minutes
Standard Deviation 124.38246
|
469.0370 minutes
Standard Deviation 103.74839
|
|
Sleep Time
3rd day post Engraftment
|
445.0000 minutes
Standard Deviation 114.98870
|
412.9545 minutes
Standard Deviation 103.99472
|
|
Sleep Time
Discharge, average 14 days
|
442.7500 minutes
Standard Deviation 139.03261
|
429.0526 minutes
Standard Deviation 142.22223
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 7, 3rd day post Engraftment, DischargePopulation: Data available only for participants who completed instrument for respective study visits.
Sleep percent measured by actigraph. Sleep percent is the percent of time spent in bed that the participant is asleep.
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=27 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=27 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Sleep Percent
Baseline
|
90.5335 percentage of time
Standard Deviation 11.90539
|
92.0426 percentage of time
Standard Deviation 6.25857
|
|
Sleep Percent
Day 2
|
88.4100 percentage of time
Standard Deviation 7.51981
|
88.9254 percentage of time
Standard Deviation 7.82651
|
|
Sleep Percent
Day 7
|
88.0265 percentage of time
Standard Deviation 7.21864
|
87.6411 percentage of time
Standard Deviation 9.11993
|
|
Sleep Percent
3rd day post Engraftment
|
86.8181 percentage of time
Standard Deviation 6.67063
|
84.2027 percentage of time
Standard Deviation 13.55268
|
|
Sleep Percent
Discharge, average 14 days
|
87.3506 percentage of time
Standard Deviation 6.22923
|
86.9674 percentage of time
Standard Deviation 9.44681
|
SECONDARY outcome
Timeframe: Baseline and DischargeMelatonin level
Outcome measures
| Measure |
Circadian Active Bright White Light (BWL)
n=27 Participants
PEI Experimental Light: Ambient Light Fixture delivery of circadian active bright white light (BWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
Circadian Inactive Dim White Light (DWL)
n=27 Participants
Comparison Light: Ambient Light Fixture delivery of circadian inactive dim white light (DWL) installed in the patient's hospital room will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
|
|---|---|---|
|
Melatonin
Baseline
|
21.5116 ng/ml
Standard Deviation 20.83586
|
41.2025 ng/ml
Standard Deviation 64.54599
|
|
Melatonin
Discharge, average 14 days
|
31.6728 ng/ml
Standard Deviation 45.04760
|
19.0317 ng/ml
Standard Deviation 23.11714
|
Adverse Events
Circadian Active Bright White Light (BWL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Circadian Inactive Dim White Light (DWL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Heiðdís B. Valdimarsdottir
Icahn School of Medicine at Mount Sinai
Phone: (212) 659-5678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place