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NCT03198754 · OUTCOME

Sleep Time

Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue · Source last updated 2020-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
minutes
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge

What was measured

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.

Analysis population: Data available only for participants who completed instrument for respective study visits.

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)27
Circadian Inactive Dim White Light (DWL)27

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)23
Circadian Inactive Dim White Light (DWL)27
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Circadian Active Bright White Light (BWL)396.0000106.94731Not reportedNot reportedNot reported
Circadian Inactive Dim White Light (DWL)444.2407120.45869Not reportedNot reportedNot reported
Day 2

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)20
Circadian Inactive Dim White Light (DWL)26
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Circadian Active Bright White Light (BWL)423.3500102.93753Not reportedNot reportedNot reported
Circadian Inactive Dim White Light (DWL)458.3077122.00419Not reportedNot reportedNot reported
Day 7

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)20
Circadian Inactive Dim White Light (DWL)27
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Circadian Active Bright White Light (BWL)422.9500124.38246Not reportedNot reportedNot reported
Circadian Inactive Dim White Light (DWL)469.0370103.74839Not reportedNot reportedNot reported
3rd day post Engraftment

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)16
Circadian Inactive Dim White Light (DWL)22
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Circadian Active Bright White Light (BWL)445.0000114.98870Not reportedNot reportedNot reported
Circadian Inactive Dim White Light (DWL)412.9545103.99472Not reportedNot reportedNot reported
Discharge, average 14 days

Analysis denominator · Participants

GroupSource count
Circadian Active Bright White Light (BWL)16
Circadian Inactive Dim White Light (DWL)19
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Circadian Active Bright White Light (BWL)442.7500139.03261Not reportedNot reportedNot reported
Circadian Inactive Dim White Light (DWL)429.0526142.22223Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        106.94731
        value
        396.0000
      2. group Id
        OG001
        spread
        120.45869
        value
        444.2407
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        102.93753
        value
        423.3500
      2. group Id
        OG001
        spread
        122.00419
        value
        458.3077
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    Day 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        124.38246
        value
        422.9500
      2. group Id
        OG001
        spread
        103.74839
        value
        469.0370
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Day 7
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        114.98870
        value
        445.0000
      2. group Id
        OG001
        spread
        103.99472
        value
        412.9545
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    3rd day post Engraftment
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        139.03261
        value
        442.7500
      2. group Id
        OG001
        spread
        142.22223
        value
        429.0526
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    Discharge, average 14 days
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      27
    units
    Participants
description
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.
dispersion Type
Standard Deviation
groups
  1. description
    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.
    id
    OG000
    title
    Circadian Active Bright White Light (BWL)
  2. description
    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.
    id
    OG001
    title
    Circadian Inactive Dim White Light (DWL)
param Type
MEAN
population Description
Data available only for participants who completed instrument for respective study visits.
reporting Status
POSTED
time Frame
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
title
Sleep Time
type
SECONDARY
unit Of Measure
minutes

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Preserved source evidence · Not medical advice